Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Because pain and depression share common neurobiological pathways and clinical manifestations, you can use similar strategies and, often, the same agents to treat both conditions when they occur together. This article from Current Psychiatry, available at http://www.currentpsychiatry.com/specialty-focus/depressive-disorders/article/chronic-pain-and-depression-treatment-of-2-culprits-in-common/6bc388cf05b07e8dc6bbc1b86f50f0bf.html, reviews different treatment options (including non-drug interventions) that can help patients with both pain and depression, as well as drug-drug interactions that can occur.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Homelessness and unstable housing situations are associated with higher rates of human immunodeficiency virus (HIV) and hepatitis C infection (HCV), according to researchers from Columbia University in New York City, McMaster University in Hamilton, Ontario, Canada, and the Ontario HIV Treatment Network in Canada. The researchers reviewed 152 studies involving 139,757 individuals who had HIV or were co-infected with HCV. The researchers found “strong evidence” that the lack of stable, secure, and adequate housing is a significant barrier to consistent and appropriate medical care, as well as the reduction of risk behaviors. For more on this research, see the Federal Practitioner article at: http://www.fedprac.com/the-publication/issue-single-view/homelessness-hiv-and-hcv/6a66b2b7db3f0299caa7aaf050129fb4/ocregister.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

Incretin-based antidiabetic drugs didn’t raise the risk of hospitalization for heart failure, according to an international observational study involving 1.5 million patients reported online in The New England Journal of Medicine. “With 3.2 million person-years of observations, we had the statistical power to robustly assess this important drug safety issue,” the investigators said. Read more on the study at Cardiology News: http://www.ecardiologynews.com/specialty-focus/heart-failure/single-article-page/incretin-based-diabetes-drugs-dont-raise-heart-failure-risk/72ea7cb26766fc17483ad005269c5da2.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

The prevalence of type 1 diabetes in people younger than age 20 increased by 23% from 2001 to 2009, and the disease now affects as many as 1.25 million Americans. This case from Clinician Reviews provides a brief overview of the diagnosis and management considerations required for successful care of these patients. The article is available at: http://www.clinicianreviews.com/the-publication/issue-single-view/the-challenges-of-type-1-diabetes-a-case-based-review/a5a6fab4483946a829d60880ec2e3a74.html.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

This patient handout from the American Thoracic Society doesn’t just list the signs and symptoms of chronic obstructive pulmonary disease (COPD); it also explains what is causing the symptoms and steps to take to get better control over them. The handout, available at http://www.thoracic.org/patients/patient-resources/resources/signs-symptoms-of-COPD.pdf, discusses symptoms such as fatigue, shortness of breath, and coughing, as well as the point at which patients should reach out to their health care providers.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Newly diagnosed native valve infectious endocarditis is not in and of itself an indication for anticoagulation. What’s less clear, however, is how one should proceed when a patient has a preexisting or coexisting indication for anticoagulation such as atrial fibrillation, deep vein thrombosis, pulmonary embolism, or a mechanical prosthetic heart valve. Recommendations for anticoagulation in patients with infectious endocarditis are summarized in this evidence-based review article from Cleveland Clinic Journal of Medicine: http://www.ccjm.org/current-issue/issue-single-view/can-patients-with-infectious-endocarditis-be-safely-anticoagulated/dbe0163aac4657c558cd476fcb1e815d.html.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.

Oncologists should take an individualized approach when making decisions about adjuvant endocrine therapies for premenopausal hormone receptor–positive, HER2-negative early breast cancer, suggests an analysis of a pair of randomized phase III trials published online in the Journal of Clinical Oncology.

Investigators led by Meredith M. Regan, Sc.D., of Dana-Farber Cancer Institute in Boston, analyzed data from the TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) trials of adjuvant endocrine therapies, comprising a total of nearly 5,000 women.

Results suggested that the absolute improvement in the 5-year breast cancer–free interval rate with exemestane plus ovarian function suppression (OFS) versus tamoxifen with or without OFS ranged from less than 1% in women with a lowest recurrence risk based on clinicopathologic factors to 10%-15% in women with a highest risk.

“TEXT and SOFT demonstrated that premenopausal women with hormone receptor–positive disease benefit, on average, from exemestane plus OFS versus tamoxifen with or without OFS. However, individualized treatment decisions should weigh the benefits against the adverse effects and costs of these therapy options,” the investigators wrote.

“In the absence of predictive biomarkers, consideration of a patient’s prognosis, as illustrated by STEPP [Subpopulation Treatment Effect Pattern Plot] analysis of a composite measure of recurrence risk in the TEXT and SOFT populations, is integral to this decision making,” they added.

In the SOFT trial, women were randomized to 5 years of tamoxifen alone (as an active comparator), tamoxifen plus OFS, or exemestane (Aromasin) plus OFS. In the TEXT trial, women were randomized to 5 years of exemestane plus OFS or of tamoxifen plus OFS.

Dr. Regan and colleagues based their analyses on a total of 4,891 women. They assessed each patient’s composite recurrence risk from a Cox model that included a set of conventional clinicopathologic factors: age, nodal status, tumor size and grade, and estrogen receptor, progesterone receptor, and Ki-67 expression levels. And they used STEPP methodology to assess the impact of endocrine therapy across groups having different risk.

The median duration of follow-up was 5.6 years in the SOFT trial and 6 years in the TEXT trial. Results showed that the 5-year breast cancer–free interval rate was 90.8% for the study cohort as a whole. But it ranged considerably from 98.6% for patients with composite risk in the lowest quartile to 77.5% for patients with composite risk in the highest quartiles, the investigators reported (J Clin Oncol. 2016. doi: 10.1200/JCO.2015.64.3171).

In the SOFT population, patients who remained premenopausal after neoadjuvant or adjuvant chemotherapy had an absolute improvement of 5% or more in the 5-year breast cancer–free interval rate with exemestane plus OFS, compared with tamoxifen plus OFS or tamoxifen alone. The difference was 10%-15% for the subset at intermediate to high risk for recurrence.

In addition, a benefit of tamoxifen plus OFS over tamoxifen alone was evident in patients having the highest composite risk.

Among patients who were not given chemotherapy, who on average had the lowest composite recurrence risk, the 5-year breast cancer–free interval rate was excellent regardless of the endocrine therapy received.

In the TEXT trial population, the benefit of exemestane plus OFS over tamoxifen plus OFS in 5-year breast cancer–free interval rate ranged from 5% to 15%. Again, the patients who were not given chemotherapy, who had the lowest composite recurrence risk, fared well regardless of which endocrine therapy they received.

These findings should help guide clinical decisions in premenopausal women with hormone receptor–positive, HER2-negative breast cancer, both at the extremes of risk and in the scenario of intermediate risk, where factors such as patient preference, tolerance, and cost play a greater role, according to the investigators.

“Further follow-up of TEXT and SOFT patients is essential to guide patient care,” they concluded.

High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

High-dose oral vitamin D supplements taken for 1 year significantly improved cardiac structure and function in patients with chronic heart failure secondary to left ventricular systolic dysfunction, according to results from a new study.

However, the same study. led by Dr. Klaus Witte of the University of Leeds (England), found that 6-minute walk distance – the study’s primary outcome measure – was not improved after a year’s supplementation with vitamin D.

©Joss/Fotolia.com

It is unclear why vitamin D deficiency co-occurs in a majority of people with chronic heart failure (CHF) due to left ventricular systolic dysfunction (LVSD) or to what degree reversing it can improve outcomes. However, vitamin D deficiency is thought to interfere with calcium transport in cardiac cells, and may contribute to cardiac fibrosis and inflammation, leading to faster progression to heart failure following damage to cardiac muscle.

The new VINDICATE study randomized 223 patients with CHF due to LVSD and vitamin D deficiency to 1 year’s treatment with 4,000 IU of 25(OH) vitamin D3 daily, or placebo, Dr. Witte and associates concluded at the annual meeting of the American College of Cardiology. The results were published online April 4 in JACC (doi: 10.1016/j.jacc.2016.03.508).

Of these patients, 163 completed follow-up at 12 months, and 6-minute walk distance (MWT) and echocardiography findings were recorded at baseline and follow-up.

Dr. Witte and colleagues found significant evidence of improved function in the vitamin D–treated patients as measured by left ventricular ejection fraction +6.07% (95% confidence interval 3.20, 8.95; P less than .0001); and a reversal of left ventricular remodeling (left ventricular end diastolic diameter –2.49 mm (95% CI –4.09, –0.90; P equal to .002) and left ventricular end systolic diameter –2.09 mm (95% CI –4.11; –0.06; P equal to .043).

The researchers also drew blood at 3-month intervals to check for serum calcium concentration, renal function, and vitamin D levels. Treatment was well tolerated, and no patients suffered hypervitaminosis or required a dose adjustment.

“There was no effect of vitamin D supplementation on the primary endpoint of 6 MWT distance but there were statistically significant, and prognostically and clinically relevant improvements in the secondary outcomes of left ventricular ejection fraction, dimensions, and volumes, suggesting that vitamin D is leading to beneficial reverse remodeling,” the investigators wrote in their analysis.

The study’s failure to meet its primary endpoint despite significant results from its secondary endpoints led Dr. Witte and colleagues to say that its design led to underpowering.

“Variability in the walk distance measure at baseline was much greater than predicted from our pilot study such that our sample size only had 7% post hoc power to detect a difference between the groups,” meaning it was underpowered to detect a clinically relevant change in walk distance. The findings “have implications for future studies using 6-minute walk distance as an outcome measure,” they wrote.

The investigators championed the addition of vitamin D₃ to CHF treatment regimens.

As new therapies for CHF are “often expensive, increasingly technical, and frequently fail to meet the rigorous demands of large phase III clinical trials,” Dr. Witte and colleagues wrote, vitamin D “might be a cheap and safe additional option for CHF patients and may have beneficial effects on multiple features of the syndrome.”

The U.K.’s National Institute for Health Research supported the study, and none of its authors declared conflicts of interest.

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The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.

The Journal of Vascular Surgery: Venous and Lymphatic Disorders is now indexed on PubMed, from Issue 1 Volume 1. PubMed is often the first stop for researchers because it comprises more than 25 million citations for biomedical literature from MEDLINE, life science journals and online books.

Not only does this accomplishment increase the visibility of the Journal, it confirms the Journal of Vascular Surgery: Venous and Lymphatic Disorders as the premier international journal of medical, endovascular and surgical care of venous and lymphatic disorders.

Only 12 to 15 percent of the journals reviewed are recommended for inclusion in MEDLINE, so it is clear that this accomplishment is due in great part to the fact that every issues of JVSVL includes high-quality and rigorously peer-reviewed articles.