Mark S. Lesney

Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services include:

▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.

▸ Requiring investigators to publish results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services include:

▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.

▸ Requiring investigators to publish results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services include:

▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.

▸ Requiring investigators to publish results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Clinical trials in the future may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if proposed revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include the following:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS is reviewing all public comments and suggestions and will incorporate them into the final published NCD, and the revised policy will be effective with that publication.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was first developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Clinical trials in the future may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if proposed revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include the following:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS is reviewing all public comments and suggestions and will incorporate them into the final published NCD, and the revised policy will be effective with that publication.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was first developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Clinical trials in the future may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if proposed revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include the following:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS is reviewing all public comments and suggestions and will incorporate them into the final published NCD, and the revised policy will be effective with that publication.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was first developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Future clinical trials may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov Web site before enrollment begins.

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS will review all public comments and suggestions and incorporate them into the final published NCD no later than 60 days after the end of the comment period, and the revised policy will be effective with that publication.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Future clinical trials may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov Web site before enrollment begins.

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS will review all public comments and suggestions and incorporate them into the final published NCD no later than 60 days after the end of the comment period, and the revised policy will be effective with that publication.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

Future clinical trials may have to conform to several new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include:

▸ Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov Web site before enrollment begins.

▸ Requiring study investigators to publish their results.

▸ Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.

▸ Paying for investigational clinical services if they are covered by Medicare outside the trial or required under CED through the national coverage determination (NCD) process.

▸ Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS will review all public comments and suggestions and incorporate them into the final published NCD no later than 60 days after the end of the comment period, and the revised policy will be effective with that publication.

Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186

WASHINGTON — Percutaneous vertebroplasty, while effective for relieving pain, has not been shown to prevent new fractures, Dr. Gregg H. Zoarski said in a state of the art review at a symposium sponsored by the Society of Interventional Radiology.

The procedure works in 85%–95% of patients who have pain localized to one or two nonsclerotic vertebrae and osteoporotic fractures that have occurred within less than 2–3 months. When pain is not localized and there are no observable deformities on imaging or fractures have been present for over 1 year, patients seldom respond well to vertebroplasty, Dr. Zoarski said.

Vertebroplasty also can be used to relieve pain caused by soft tumors in the vertebrae, including myelomas. For patients with neoplastic fractures, pain relief ranges from 60% to 90%, said Dr. Zoarski, professor of diagnostic radiology at the University of Maryland, Baltimore, and director of diagnostic and interventional radiology at the University of Maryland Hospital.

In addition, vertebroplasty and kyphoplasty are “tremendously safe procedures,” according to Dr. Zoarski. “Minor complications should be less than 3% and major complications should be well less than 1%,” he stated. Less clear is whether vertebroplasty, like surgical intervention, actually increases the risk of adjacent vertebral fractures.

In small follow-up studies, there was no statistically significant increase in adjacent fractures with vertebroplasty. A retrospective study of 177 patients, however, found a significantly higher rate of adjacent fractures within 30 days of the procedure, and 67% of new fractures occurred adjacent to treated vertebrae, he said.

The natural history of osteoporosis and nonuniform stress within the spine may create a “hot spot” where subsequent fractures are likely to occur, irrespective of intervention. Biomechanical studies are uneven in terms of predicting fracture location.

With regard to both vertebroplasty and kyphoplasty, “I think we have to conclude that there is mixed data on this and we cannot clearly state whether the procedure is going to prevent or cause adjacent fractures,” Dr. Zoarski said. The need for vertebroplasty or other interventional treatments is relatively high, especially because surgery isn't an option for many patients with poor bony substrate or comorbidities.

Noninterventional alternatives have their own complications. Bed rest can exacerbate bone deterioration and decrease patient strength. Bracing has compliance problems, and removal of the brace causes patients “to regress to the same level of deformity that they would have [had] without the brace.” Medications for pain can interact with other drugs as well as directly contribute to morbidity. Dr. Zoarski stated that he had no financial relationships to disclose in regard to percutaneous vertebroplasty.

WASHINGTON — Percutaneous vertebroplasty, while effective for relieving pain, has not been shown to prevent new fractures, Dr. Gregg H. Zoarski said in a state of the art review at a symposium sponsored by the Society of Interventional Radiology.

The procedure works in 85%–95% of patients who have pain localized to one or two nonsclerotic vertebrae and osteoporotic fractures that have occurred within less than 2–3 months. When pain is not localized and there are no observable deformities on imaging or fractures have been present for over 1 year, patients seldom respond well to vertebroplasty, Dr. Zoarski said.

Vertebroplasty also can be used to relieve pain caused by soft tumors in the vertebrae, including myelomas. For patients with neoplastic fractures, pain relief ranges from 60% to 90%, said Dr. Zoarski, professor of diagnostic radiology at the University of Maryland, Baltimore, and director of diagnostic and interventional radiology at the University of Maryland Hospital.

In addition, vertebroplasty and kyphoplasty are “tremendously safe procedures,” according to Dr. Zoarski. “Minor complications should be less than 3% and major complications should be well less than 1%,” he stated. Less clear is whether vertebroplasty, like surgical intervention, actually increases the risk of adjacent vertebral fractures.

In small follow-up studies, there was no statistically significant increase in adjacent fractures with vertebroplasty. A retrospective study of 177 patients, however, found a significantly higher rate of adjacent fractures within 30 days of the procedure, and 67% of new fractures occurred adjacent to treated vertebrae, he said.

The natural history of osteoporosis and nonuniform stress within the spine may create a “hot spot” where subsequent fractures are likely to occur, irrespective of intervention. Biomechanical studies are uneven in terms of predicting fracture location.

With regard to both vertebroplasty and kyphoplasty, “I think we have to conclude that there is mixed data on this and we cannot clearly state whether the procedure is going to prevent or cause adjacent fractures,” Dr. Zoarski said. The need for vertebroplasty or other interventional treatments is relatively high, especially because surgery isn't an option for many patients with poor bony substrate or comorbidities.

Noninterventional alternatives have their own complications. Bed rest can exacerbate bone deterioration and decrease patient strength. Bracing has compliance problems, and removal of the brace causes patients “to regress to the same level of deformity that they would have [had] without the brace.” Medications for pain can interact with other drugs as well as directly contribute to morbidity. Dr. Zoarski stated that he had no financial relationships to disclose in regard to percutaneous vertebroplasty.

WASHINGTON — Percutaneous vertebroplasty, while effective for relieving pain, has not been shown to prevent new fractures, Dr. Gregg H. Zoarski said in a state of the art review at a symposium sponsored by the Society of Interventional Radiology.

The procedure works in 85%–95% of patients who have pain localized to one or two nonsclerotic vertebrae and osteoporotic fractures that have occurred within less than 2–3 months. When pain is not localized and there are no observable deformities on imaging or fractures have been present for over 1 year, patients seldom respond well to vertebroplasty, Dr. Zoarski said.

Vertebroplasty also can be used to relieve pain caused by soft tumors in the vertebrae, including myelomas. For patients with neoplastic fractures, pain relief ranges from 60% to 90%, said Dr. Zoarski, professor of diagnostic radiology at the University of Maryland, Baltimore, and director of diagnostic and interventional radiology at the University of Maryland Hospital.

In addition, vertebroplasty and kyphoplasty are “tremendously safe procedures,” according to Dr. Zoarski. “Minor complications should be less than 3% and major complications should be well less than 1%,” he stated. Less clear is whether vertebroplasty, like surgical intervention, actually increases the risk of adjacent vertebral fractures.

In small follow-up studies, there was no statistically significant increase in adjacent fractures with vertebroplasty. A retrospective study of 177 patients, however, found a significantly higher rate of adjacent fractures within 30 days of the procedure, and 67% of new fractures occurred adjacent to treated vertebrae, he said.

The natural history of osteoporosis and nonuniform stress within the spine may create a “hot spot” where subsequent fractures are likely to occur, irrespective of intervention. Biomechanical studies are uneven in terms of predicting fracture location.

With regard to both vertebroplasty and kyphoplasty, “I think we have to conclude that there is mixed data on this and we cannot clearly state whether the procedure is going to prevent or cause adjacent fractures,” Dr. Zoarski said. The need for vertebroplasty or other interventional treatments is relatively high, especially because surgery isn't an option for many patients with poor bony substrate or comorbidities.

Noninterventional alternatives have their own complications. Bed rest can exacerbate bone deterioration and decrease patient strength. Bracing has compliance problems, and removal of the brace causes patients “to regress to the same level of deformity that they would have [had] without the brace.” Medications for pain can interact with other drugs as well as directly contribute to morbidity. Dr. Zoarski stated that he had no financial relationships to disclose in regard to percutaneous vertebroplasty.

Women with sexual dysfunction maintained elevated levels of sex hormone-binding globulin even after they discontinued use of oral contraceptives, according to Dr. Claudia Panzer of Boston University Medical Center and her colleagues.

In a retrospective study of sex hormone-binding globulin (SHBG) levels before and after discontinuation of oral contraceptive use, researchers examined 124 premenopausal women with sexual health complaints. The women were divided into three groups: “continued-users,” 62 women (mean age 32 years) who had been on OCs for more than 6 months and continued taking them; “discontinued-users,” 39 women (mean age 33 years) who had been on OCs for longer than 6 months and discontinued them; and “never-users,” 23 women (mean age 36 years) who had never taken OCs.

SHBG was a significant four times higher in the continued-user group, compared with the never-user group (152 nmol/L vs. 41 nmol/L). But despite a decreased level of SHBG in the discontinued-user group, the level remained significantly higher than in the never-user group for more than 120 days, according to the investigators (J. Sex. Med. 2006;3:104–13). (See graphic.)

SHBG elevation induced by OCs may lead to long-term sexual, metabolic, and mental health changes, the investigators said.

ELSEVIER GLOBAL MEDICAL NEWS

Women with sexual dysfunction maintained elevated levels of sex hormone-binding globulin even after they discontinued use of oral contraceptives, according to Dr. Claudia Panzer of Boston University Medical Center and her colleagues.

In a retrospective study of sex hormone-binding globulin (SHBG) levels before and after discontinuation of oral contraceptive use, researchers examined 124 premenopausal women with sexual health complaints. The women were divided into three groups: “continued-users,” 62 women (mean age 32 years) who had been on OCs for more than 6 months and continued taking them; “discontinued-users,” 39 women (mean age 33 years) who had been on OCs for longer than 6 months and discontinued them; and “never-users,” 23 women (mean age 36 years) who had never taken OCs.

SHBG was a significant four times higher in the continued-user group, compared with the never-user group (152 nmol/L vs. 41 nmol/L). But despite a decreased level of SHBG in the discontinued-user group, the level remained significantly higher than in the never-user group for more than 120 days, according to the investigators (J. Sex. Med. 2006;3:104–13). (See graphic.)

SHBG elevation induced by OCs may lead to long-term sexual, metabolic, and mental health changes, the investigators said.

ELSEVIER GLOBAL MEDICAL NEWS

Women with sexual dysfunction maintained elevated levels of sex hormone-binding globulin even after they discontinued use of oral contraceptives, according to Dr. Claudia Panzer of Boston University Medical Center and her colleagues.

In a retrospective study of sex hormone-binding globulin (SHBG) levels before and after discontinuation of oral contraceptive use, researchers examined 124 premenopausal women with sexual health complaints. The women were divided into three groups: “continued-users,” 62 women (mean age 32 years) who had been on OCs for more than 6 months and continued taking them; “discontinued-users,” 39 women (mean age 33 years) who had been on OCs for longer than 6 months and discontinued them; and “never-users,” 23 women (mean age 36 years) who had never taken OCs.

SHBG was a significant four times higher in the continued-user group, compared with the never-user group (152 nmol/L vs. 41 nmol/L). But despite a decreased level of SHBG in the discontinued-user group, the level remained significantly higher than in the never-user group for more than 120 days, according to the investigators (J. Sex. Med. 2006;3:104–13). (See graphic.)

SHBG elevation induced by OCs may lead to long-term sexual, metabolic, and mental health changes, the investigators said.

ELSEVIER GLOBAL MEDICAL NEWS

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification.

Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601 were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving approximately 405,000 patients. Outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” the researchers reported.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified.

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification.

Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601 were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving approximately 405,000 patients. Outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” the researchers reported.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified.

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification.

Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601 were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving approximately 405,000 patients. Outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” the researchers reported.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified.

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study that used the results of the National Health and Nutrition Examination Survey 1999–2002 to evaluate a variety of possible risk factors.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah. The investigators used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and they used presumptive risk factors as covariates to model the occurrence of the condition.

PVD in patients under age 60 years is considered premature, according to the researchers. Premature PVD is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt only with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age 49) with those 60 years and older (mean age 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group.

A history of coronary artery disease appeared to be highly predictive of PVD in the population under age 60. The odds ratio was 2.9 for this younger group, compared with approximately 1.3 for the older population.

In an analysis of the other possible risk factors, the researchers found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the PVDodds ratio. There was no significant correlation in the younger age group, the researchers reported.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' It was important to confirm this in a large population-based study. The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” Dr. Messina added.

Information on NHANES and its data sets is available at www.cdc.gov/nchs/nhanes.htm

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study that used the results of the National Health and Nutrition Examination Survey 1999–2002 to evaluate a variety of possible risk factors.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah. The investigators used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and they used presumptive risk factors as covariates to model the occurrence of the condition.

PVD in patients under age 60 years is considered premature, according to the researchers. Premature PVD is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt only with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age 49) with those 60 years and older (mean age 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group.

A history of coronary artery disease appeared to be highly predictive of PVD in the population under age 60. The odds ratio was 2.9 for this younger group, compared with approximately 1.3 for the older population.

In an analysis of the other possible risk factors, the researchers found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the PVDodds ratio. There was no significant correlation in the younger age group, the researchers reported.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' It was important to confirm this in a large population-based study. The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” Dr. Messina added.

Information on NHANES and its data sets is available at www.cdc.gov/nchs/nhanes.htm

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study that used the results of the National Health and Nutrition Examination Survey 1999–2002 to evaluate a variety of possible risk factors.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah. The investigators used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and they used presumptive risk factors as covariates to model the occurrence of the condition.

PVD in patients under age 60 years is considered premature, according to the researchers. Premature PVD is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt only with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age 49) with those 60 years and older (mean age 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group.

A history of coronary artery disease appeared to be highly predictive of PVD in the population under age 60. The odds ratio was 2.9 for this younger group, compared with approximately 1.3 for the older population.

In an analysis of the other possible risk factors, the researchers found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the PVDodds ratio. There was no significant correlation in the younger age group, the researchers reported.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' It was important to confirm this in a large population-based study. The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” Dr. Messina added.

Information on NHANES and its data sets is available at www.cdc.gov/nchs/nhanes.htm

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification. Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a significantly greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the number of patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving about 405,000 patients. Full outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” according to the researchers.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified. Lipid control goals were those defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines.

“Our current study demonstrates that improvements in lipid control and statin usage, and attainment of national lipid goals, are highly achievable in a PAD population that is treated in a disease management fashion,” the researchers stated.

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification. Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a significantly greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the number of patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving about 405,000 patients. Full outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” according to the researchers.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified. Lipid control goals were those defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines.

“Our current study demonstrates that improvements in lipid control and statin usage, and attainment of national lipid goals, are highly achievable in a PAD population that is treated in a disease management fashion,” the researchers stated.

Patients with peripheral arterial disease often are undertreated with regard to atherosclerotic risk factor modification. Such patients can benefit from the use of a clinical pharmacy service in conjunction with physician recommendations for lipid control, according to Dr. Thomas F. Rehring and colleagues from the Kaiser Permanente Colorado Region and the University of Colorado Health Sciences Center in Denver.

In a cohort of 691 outpatients with peripheral arterial disease (PAD) validated by noninvasive arterial study, 90 patients were enrolled into a pharmacist-managed, physician-monitored algorithmic approach for the management of lipids, and 601were given standard care, according to Dr. Rehring, of the vascular surgery department at Kaiser Permanente, and his colleagues. They presented the results of their research at the annual meeting of the Western Vascular Society in Deer Valley, Utah.

Low-density lipoprotein cholesterol (LDL-C) control goals were achieved by a significantly greater percentage of the pharmacist-managed group (79%) than the standard treatment group (54%). And a significant difference in the number of patients with LDL-C values over 130 mg/dL was noted between the treatment (1.2%) and control (14%) groups. In the control group, nearly 52% of patients used statins, compared with 84% of the pharmacist-managed group, a statistically significant difference.

All patients in the study were members of a not-for-profit managed care system serving about 405,000 patients. Full outpatient records of medical, pharmacy, laboratory, and radiology information were stored electronically, allowing for “current and comprehensive analysis,” according to the researchers.

Mean follow-up was slightly more than 17 months. Fasting lipid profiles were screened in 95% (86/90) of the patients in the algorithmic group and nearly 67% (402/601) of the standard care group.

All patients accepting enrollment in the algorithmic approach interacted regularly with a pharmacist-manager who collected data, monitored medication and laboratory compliance while making treatment plan adjustments, and kept the responsible primary care physician notified. Lipid control goals were those defined by the National Cholesterol Education Program Adult Treatment Panel III guidelines.

“Our current study demonstrates that improvements in lipid control and statin usage, and attainment of national lipid goals, are highly achievable in a PAD population that is treated in a disease management fashion,” the researchers stated.

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study based on data from the National Health and Nutrition Examination Survey 1999–2002.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah.

The researchers used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and used presumptive risk factors as covariates to model the occurrence of PVD.

Premature PVD—occurring in patients under age 60 years—is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age approximately 49) with those 60 years and older (mean age approximately 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group, a highly significant difference.

A history of coronary artery disease appeared to be highly predictive of PVD in persons who were under age 60 (premature PVD). The odds ratio was 2.9 for this younger group, compared with about 1.3 for the older population.

“It is not surprising that atherosclerotic disease in the peripheral vascular bed is found concomitantly with disease in the coronary vascular bed,” the researchers wrote. “However, the strength of the interaction between younger and older patients deserves emphasis. PVD in the younger age group is much more strongly associated with other cardiovascular conditions than in the older population.”

In an analysis of the other possible risk factors, they found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the odds ratio for PVD. There was no significant correlation in the younger age group, according to the researchers.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“This study is the first paper to address the question as to what risk factors for atherosclerosis might distinguish premature-onset atherosclerosis from that seen in the 60− and 70-year age groups,” Dr. Messina said in an interview.

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” he added.

NHANES information and its data sets are at www.cdc.gov/nchs/nhanes.htm

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study based on data from the National Health and Nutrition Examination Survey 1999–2002.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah.

The researchers used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and used presumptive risk factors as covariates to model the occurrence of PVD.

Premature PVD—occurring in patients under age 60 years—is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age approximately 49) with those 60 years and older (mean age approximately 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group, a highly significant difference.

A history of coronary artery disease appeared to be highly predictive of PVD in persons who were under age 60 (premature PVD). The odds ratio was 2.9 for this younger group, compared with about 1.3 for the older population.

“It is not surprising that atherosclerotic disease in the peripheral vascular bed is found concomitantly with disease in the coronary vascular bed,” the researchers wrote. “However, the strength of the interaction between younger and older patients deserves emphasis. PVD in the younger age group is much more strongly associated with other cardiovascular conditions than in the older population.”

In an analysis of the other possible risk factors, they found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the odds ratio for PVD. There was no significant correlation in the younger age group, according to the researchers.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“This study is the first paper to address the question as to what risk factors for atherosclerosis might distinguish premature-onset atherosclerosis from that seen in the 60− and 70-year age groups,” Dr. Messina said in an interview.

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” he added.

NHANES information and its data sets are at www.cdc.gov/nchs/nhanes.htm

Coronary artery disease and elevated serum fibrinogen were stronger predictors of peripheral vascular disease in subjects younger than 60 years than in older subjects, according to a study based on data from the National Health and Nutrition Examination Survey 1999–2002.

Chronic renal insufficiency was more highly predictive of peripheral vascular disease (PVD) in subjects aged 60 years and over, according to Dr. Louis M. Messina and colleagues at the University of California, San Francisco. Their analysis was presented at the annual meeting of the Western Vascular Society, Deer Valley, Utah.

The researchers used the NHANES data to determine the prevalence of premature PVD in the U.S. population, and used presumptive risk factors as covariates to model the occurrence of PVD.

Premature PVD—occurring in patients under age 60 years—is associated with an extremely poor prognosis, including high rates of cardiovascular morbidity, limb loss, and premature death. Previous studies have been small, have dealt with a limited number of risk factors, and focused on coronary vascular disease as the outcome of interest, according to the researchers.

Based on the hypothesis that there was an interaction between risk factors and age, the investigators analyzed the data to compare the population aged less than 60 years (mean age approximately 49) with those 60 years and older (mean age approximately 70).

NHANES began to provide data in 1999 from detailed lower extremity examinations, including measurement of the ankle-brachial index (ABI). An ABI of less than 0.9 was considered indicative of lower peripheral vascular disease, according to the researchers, and was correlated with the other variables collected in the sampled population. Previous research has shown that a low ABI is one of the strongest predictors of cardiovascular morbidity and all-cause mortality.

The investigators compared data from 2,498 patients under age 60 with those from 2,585 patients aged 60 years and older. Peripheral vascular disease rates were approximately 2% in the younger group and 12% in the older group, a highly significant difference.

A history of coronary artery disease appeared to be highly predictive of PVD in persons who were under age 60 (premature PVD). The odds ratio was 2.9 for this younger group, compared with about 1.3 for the older population.

“It is not surprising that atherosclerotic disease in the peripheral vascular bed is found concomitantly with disease in the coronary vascular bed,” the researchers wrote. “However, the strength of the interaction between younger and older patients deserves emphasis. PVD in the younger age group is much more strongly associated with other cardiovascular conditions than in the older population.”

In an analysis of the other possible risk factors, they found that a 10-mg/dL increase in fibrinogen was associated with a 7% increase in odds in subjects under age 60, compared with a 3% increase in patients 60 years and older.

Although the authors did not believe this result was sufficient to indicate wide-scale screening of high fibrinogen levels to detect PVD, they did suggest that it may have clinical relevance for secondary intervention, since fibrates and niacin can lower fibrinogen levels.

In contrast, a decreased creatinine clearance was significantly associated with PVD in individuals aged 60 and older, with a 10-unit decrease in clearance affording a 16% increase in the odds ratio for PVD. There was no significant correlation in the younger age group, according to the researchers.

Strong risk factors that are independently associated with PVD regardless of age category include smoking and hypertension. Metaanalysis of plasma homocysteine levels showed only a weak association with the development of PVD.

Although there was no difference found in risk associated with gender between the age groups, being male was a significant overall predictor (odds ratio slightly greater than 2.0).

“This study is the first paper to address the question as to what risk factors for atherosclerosis might distinguish premature-onset atherosclerosis from that seen in the 60− and 70-year age groups,” Dr. Messina said in an interview.

“That premature peripheral vascular disease is associated with elevated fibrinogen suggests what many had suspected but not proven, that premature PVD is associated with a 'hypercoagulable state.' The other important risk factor was the presence of coronary artery disease. That coronary artery disease correlated more closely with premature peripheral vascular disease in those less than 60 years of age is equally surprising,” he added.

NHANES information and its data sets are at www.cdc.gov/nchs/nhanes.htm

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease (CHD) database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal CHD from 1987 to 2001, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant standardized incidence ratio (SIR) for CHD in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status in all age groups for both men and women—except for those in the 70–79 age group.

Two groups of patients were compared from the larger database. The first group studied had been hospitalized for depression, followed by CHD hospitalization (n = 1,916). The second group only had been hospitalized for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease (CHD) database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal CHD from 1987 to 2001, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant standardized incidence ratio (SIR) for CHD in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status in all age groups for both men and women—except for those in the 70–79 age group.

Two groups of patients were compared from the larger database. The first group studied had been hospitalized for depression, followed by CHD hospitalization (n = 1,916). The second group only had been hospitalized for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.

Depression is a clinically significant risk factor for developing coronary heart disease, especially in men and women aged 25–50, according to an analysis of a national family database at the Karolinska Institute, Stockholm.

Data from the family coronary heart disease (CHD) database at the institute were used to identify all people in Sweden aged 25–64 at the onset of depression, and aged 25–79 at the onset of nonfatal CHD from 1987 to 2001, reported Jan Sunquist, Ph.D., and colleagues from the Center for Family and Community Medicine, Huddinge, Sweden (Am. J. Prev. Med. 2005;29:428–33).

Significant standardized incidence ratio (SIR) for CHD in depressive patients was greatest in the 25–39 age group in both men (SIR = 2.97) and women (SIR = 3.04) and remained significant after adjustment for socioeconomic status in all age groups for both men and women—except for those in the 70–79 age group.

Two groups of patients were compared from the larger database. The first group studied had been hospitalized for depression, followed by CHD hospitalization (n = 1,916). The second group only had been hospitalized for nonfatal CHD (n = 425,495). Both depression and CHD had to be diagnosed based on World Health Organization ICD criteria.

The researchers believe that their results have important clinical implications for preventive care. “Primary health care teams meet patients with depression, and it is important that they treat depression as an individual and independent CHD risk factor,” the researchers wrote.