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Category: CVD Prevention

Big Data for Better Hearts

The genomics revolution has brought personalized medicine to cancer and rare diseases; an EU-funded initiative aims to bring cardiovascular care into the genomics era. The €19 million project, funded by the EU’s Innovative Medicines Initiative, was launched in order to apply the power of genomics and big data to cardiovascular health.

The project is a recognition that in the face of the enormous burden of heart failure, atrial fibrillation and acute coronary syndrome, the field lags behind other major disease areas in using genomic and big data to improve patient outcomes.

It is hoped that the outputs will lead to a major revamp of clinical guidelines in cardiology. The researchers involved in BigData@Heart have been instrumental in shaping current treatment and management of heart conditions and there is an emerging consensus that these should be updated to reflect advances in big data.

“Today’s treatment guidelines reflect the scientific constraints of an earlier era where clinical markers to guide therapy were limited to conventional risk factors and end-organ damage, and where the main endpoint in clinical trials is patient death and hospitalization,” said project member Stefan Anker of Charité University Medicine, Berlin. “Our goal is to build a much more personalized, data-driven system that brings cardiology into the ‘omics era.”

While the treatment of cardiovascular diseases has improved vastly in recent decades, the human and economic cost of lost productivity, hospitalization and death remains substantial, said Maureen Cronin of the pharmaceutical company Vifor Pharma, a co-lead of the project. “Advances in ‘omics have changed how we think about disease but have not been fully embraced in cardiovascular disease. If you look to oncology and rare diseases, there has been much greater progress.”

A simple blood test can help predict the risk of developing breast cancer, or guide doctors in selecting cancer drugs. This more personalized approach to cancer care is the result of decades of genetics research and advances in diagnostic testing. Similarly, genomics is making a major contribution to the diagnosis and treatment of rare diseases.

So for example, the National Health Service in England now makes DNA sequencing of tumors to identify mutations against which there are targeted drugs, an integrated part of clinical care. In inherited rare diseases, the genomes of patients are being sequenced in order to try and reach a diagnosis and to inform treatment. Cancers and rare diseases are amenable to this approach because in most cases they are driven by mutations. Cardiovascular diseases, in contrast, tend to have more heterogeneous etiologies, and patients often have comorbidities.

“In cardiovascular conditions, there is most likely a genetic component but the relative roles of genetics, comorbidities, such as hypertension, diabetes or kidney disease and risk factors, such as exercise and diet are not yet fully elucidated,” said Folkert Asselbergs of UMC Utrecht and University College London. “This complicates our understanding of a patient’s prognosis.”

However, advances in computing power and the availability of large patient data sets could allow researchers to build algorithms that take account of a patient’s genes, lifestyles and other chronic illnesses. Ultimately, said Asselbergs, this would pave the way for a more individualized and efficient approach to therapy.

BigData@Heart is one of four disease-specific projects exploring how to use patient information to improve outcomes being funded by IMI. The €5.3 billion collaboration between the pharmaceutical industry and the European Commission is designed to speed up drug discovery and development, through investments in research infrastructure, streamlining clinical trials processes and promoting data sharing.

“Thanks to this public-private partnership approach, BigData@Heart has access to most of the relevant large-scale European cardiovascular disease databases, ranging from electronic health records and disease registries to clinical trials and large epidemiological cohorts,” said Rick Grobee, UMC Utrecht and academic leader of the project. “This brings together data from more than five million cases of atrial fibrillation, heart failure and acute coronary syndrome, as well as [that of] over 16 million healthy individuals.”

Building on the experience gained in other IMI projects, the researchers will use machine learning and data mining to design prognosis algorithms that can predict patient outcomes. The system will use an individual’s medical history, along with hospitalization rates and country-specific statistics for similar patients, to advise on the best course of treatment and the likely results.

Along with more tailored use of existing treatments, the consortium hopes to identify new drug targets. The development pipeline for cardiovascular drugs is slow, expensive and high-risk, Cronin noted. “The chance of eventual approval for a cardiovascular disease drug candidate in Phase I trials is 7 per cent, the lowest of any disease category – along with oncology,” she said. “We need better definitions of these diseases, their markers and endpoints, as well as better segmentation of patient populations. In defining disease outcomes, we must listen to patients and take account of what matters to them, including functional capacity and quality of life.”

The project will run to 2022, focusing on six pilot studies and will also address ethical and regulatory issues. Central to this will be finding ways to access patient data while safeguarding personal privacy, and agreeing on the essential elements of electronic patient records. Cronin says getting that right will make or break Europe’s efforts to catch up with the US in the race to unlock the potential of big data in healthcare.

“The US precision medicine initiative is taking these issues seriously,” she says. “In the EU, the complexities of managing data in several countries, each with its own health system, mean there is a lot of catching up to do. We need to be sure that Europe is not left behind.”

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Cardio Killers

Heart disease and tobacco ranked with conflict and violence among the world’s biggest killers in 2016, while poor diets and mental disorders caused people the greatest ill health, a large international study has found.

The Global Burden of Disease (GBD) study, published on Friday in The Lancet medical journal, found that while life expectancy is increasing, so too are the years people live in poor health. The proportion of life spent being ill is higher in poor countries than in wealthy ones.

“Death is a powerful motivator, both for individuals and for countries, to address diseases that have been killing us at high rates. But we’ve been much less motivated to address issues leading to illnesses,” said Christopher Murray, director of the Institute for Health Metrics and Evaluation (IHME) at the University of Washington, which led the study. He said a “triad of troubles” – obesity, conflict, and mental illness – is emerging as a “stubborn and persistent barrier to active and vigorous lifestyles”.

The IHME-led study, involving more than 2,500 researchers in around 130 countries, found that in 2016, poor diet was associated with nearly one in five deaths worldwide. Tobacco smoking killed 7.1 million people.

Diets low in whole grains, fruit, nuts and seeds, fish oils and high in salt were the most common risk factors, contributing to cases of obesity, high blood pressure, high blood sugar and high cholesterol.

The study found that deaths from firearms, conflict and terrorism have increased globally, and that non-communicable, or chronic, diseases such as cardiovascular disease and diabetes caused 72 percent of all deaths worldwide.

Heart disease was the leading cause of premature death in most regions and killed 9.48 million people globally in 2016. Mental illness was found to have a heavy toll on individuals and societies, with 1.1 billion people living with psychological or psychiatric disorders and substance abuse problems in 2016. Major depressive disorders ranked in the top 10 causes of ill health in all but four countries worldwide.

The GBD is funded by the Bill & Melinda Gates Foundation global health charity and gives data estimates on some 330 diseases, causes of death and injuries in 195 countries and territories.

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Pick Up the Pace!

According to a new study, healthy adults who are slow walkers are twice as likely to die from heart disease as those of us who walk at a more brisk pace. “This suggests that habitual walking pace is an independent predictor of heart-related death,” lead author Professor Tom Yates said.

Researchers from the University of Leicester followed 420,727 people over a period of six years to assess death rates.  Those who were slow walkers were found to be between 1.8 and 2.4 times more likely to die of heart disease – which is the world’s biggest killer – during the timeframe.

The researchers took into account risk factors including smoking, BMI and diet, but found that the conclusion still applied to both men and women. However, it was actually adults with the lowest BMIs who were found to have the highest risk from walking slowly.

The study’s authors believe that walking pace is an indicator of overall health and fitness as it’s strongly linked to exercise tolerance.

“Self-reported walking pace could be used to identify individuals who have low physical fitness and high mortality risk,” said Professor Yates. The researchers also looked into whether walking pace could be linked to cancer, but no connection was found.

This is not the first study to link heart disease and walking pace though – research from 2009 concluded that walking slowly is “strongly associated” with an increased risk of dying from cardiovascular disease, including heart disease and stroke.

Heart disease is often a result of high blood pressure, obesity and high cholesterol, and is the leading cause of death in the US, second only to dementia in the UK.

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Heart Disease: Linked to Dementia

A recent NIH-funded study suggests that middle-aged people with risk factors for cardiovascular disease, including heart attacks and stroke, are more likely to develop dementia in old age than people without vascular risk factors.

The study, published in JAMA Neurology, included factors like diabetes, high blood pressure and smoking. “With an aging population, dementia is becoming a greater health concern. This study supports the importance of controlling vascular risk factors like high blood pressure early in life in an effort to prevent dementia as we age,” said Walter J. Koroshetz, MD, director of NIH’s National Institute of Neurological Disorders and Stroke.

The NIH has funded a public health campaign titled “Mind Your Risks,” with the goal of raising awareness of the strong correlation between cardiovascular and brain health. “What’s good for the heart is good for the brain,” says Koroshetz. Among the study’s participants, smoking in middle age was associated with 41% higher odds of dementia; diabetes was linked to a 77% greater risk.

The study’s results contribute to a growing body of evidence and scientific literature that links midlife vascular health to dementia, including the potential of modifying the vascular risk factors to lessen the possibility of dementia. Factors like obesity, diabetes, high blood pressure, and smoking can all be controlled–over time, reducing the risk of dementia.

By focusing on risk factors before middle age, patients have an opportunity to treat and reverse these factors, with the ultimate goal of reducing dementia risk before it is too late.

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Risks of Poor Medication Adherence

A recent study published in the journal Diabetes Care indicates that poor medication adherence in adults diagnosed with type 2 diabetes is strongly associated with increased risks for “cardiovascular disease, all-cause mortality, and hospitalizations.” Conversely, when patients have good medication adherence, these risks are reduced.

The Leicester Diabetes Center at Leicester General Hospital, in conjunction with the Diabetes Research Centre at the University of Leicester in Southmead, United Kingdom, conducted a meta-analysis surrounding eight observational studies in order to determine the correlation between medication adherence and risk for cardiovascular disease (CVD)—in addition to hospitalization and mortality rates—among adults with type 2 diabetes.

The studies’ poor adherence statistics ranged from 25% to 91%, with a mean of 37.8%; one study demonstrated that there was a decrease in CVD with good medication adherence. Other studies reported that good adherence was further associated with benefits in reduced hospitalization rates. The researchers wrote: “In conjunction with previous studies, these data should encourage health care professionals to routinely assess adherence in clinical practice and make efforts to improve it where it falls below 80%…in addition, our findings should serve to reinforce to patients the importance of taking medications as prescribed, in order to avoid premature death and preventable admissions to the hospital.”

Numerous other studies confirm that poor medication adherence is particularly common among patients with cardiovascular disease, and results in serious adverse health consequences. The American Heart Association cites that medication nonadherence results in approximately 125,000 preventable deaths per year, in addition to dramatically increased risks of hospitalization and premature death. Moreover, medication adherence leads to increased health care costs for both individuals and the health care system.

In order to address the variety of potential reasons for poor medication adherence, in addition to an assessment of solutions that could close the adherence gap, the 12th Annual CMHC will host a pre-conference Business of Medicine day on Wednesday, October 4th, featuring an expert discussion hosted by Robert H. Eckel, MD, and William H. Polonsky, PhD, CDE: “The Psychology Behind Patient Adherence.” Register for the upcoming conference in Boston from October 4-7, and learn about the various methods of diagnosis, treatment, and prevention of cardiometabolic disease.

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Stopping Cholesterol-Lowering Drugs Could be Deadly

A new study confirms that stopping a cholesterol-lowering drug can be critically dangerous. Researchers found that people who stopped taking statins, after reporting a side effect, were 13% more likely to die, or have a hear attack or stroke over the next four years.


Statins work by inhibiting the liver’s ability to produce cholesterol, while simultaneously helping the organ remove existing fats in the blood. These drugs are ‘almost universally prescribed’ to people with cardiovascular disease; moreover, the U.S. Preventive Services Task Force recommends the drugs to people ages 40-75, who have no history of heart disease, if they have one or more risk factors.

While there is extensive literature and clinical studies surrounding the efficacy of statins, a quarter to a half of patients stop taking the drugs within six months to a year, according to Dr. Alexander Turchin of Brigham and Women’s Hospital in Boston. In order to determine whether people who continue taking statins fare better than those who do not, researchers analyzed data from two Boston hospitals between 2000 and 2011.

During that period, over 200,000 adults were prescribed and treated with statins; almost 45,000 of those people reported a side effect that they thought might be from the medication: generally muscle or stomach aches. The researchers focused on 28,266 people from those 45,000 with possible side effects: most of them, 19,989 individuals, continued to take the statins.

Approximately four years after the side effects were reported, 3,677 patients had died, or suffered a heart attack or stroke. Overall, researchers found that people who stopped taking statins were 13 percent more likely to die or have a heart attack, or stroke. According to Dr. Robert Rosenson, a professor of cardiology at the Icahn School of Medicine at Mount Sinai in New York City, these new findings further confirm and expand on previous studies that demonstrated the benefits of continuing to take statins.

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Breastfeeding May Lower Risk of Heart Disease & Stroke

While there is extensive research documenting the benefits of breastfeeding for babies, a new study published in the Journal of the American Heart Association indicates that the practice may lessen a mother’s risk of heart disease and stroke. Moreover, researchers found that a mother’s risk of cardiovascular disease further decreased with each additional 6 months of breastfeeding. Previous studies have suggested that women who breastfeed may experience short-term reductions in blood pressure, cholesterol, and weight loss, which likely benefit cardiovascular health.

The study, conducted in China, analyzed data from 289,754 Chinese women who were free of cardiovascular disease at the study’s baseline; almost all participants had children. The study required the women to provide information surrounding reproductive history, including whether or not they had breastfed children and the duration of breastfeeding.

The researchers assessed the incidence of heart disease and stroke among the women over an eight year follow-up, ultimately finding that women who had breastfed children were at a 9% lower risk of heart disease and an 8% lower risk of stroke, compared to those who had not breastfed. When looking at the results by breastfeeding duration, results revealed that women who had breastfed children for 2 years or longer were 18 percent less likely to develop heart disease and 17% less likely to have a stroke. For every 6 additional months of breastfeeding, risks of heart disease and stroke were respectively reduced by 4% and 3%.

Heart disease is the leading cause of death for both men and women in the United States; statistics from the Centers for Disease Control and Prevention report that approximately 610,000 people die from heart disease each year, accounting for 1 in every 4 deaths. Likewise, stroke is one of the country’s leading causes of disability: there are more than 795,000 people in the U.S. who have a stroke annually.

Senior author Zhengming Chen of the University of Oxford states that “the findings should encourage more widespread breast-feeding for the benefit of the mother as well as the child.”

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Type 2 Diabetes and Heart Failure: A Deadly Combination

An in-depth session titled “Heart Failure: The Frequent, Forgotten, and Often Fatal Complication of Type 2 Diabetes” was presented last week at the American Association of Clinical Endocrinology’s 26th Annual Scientific and Clinical Congress. The cited evidence and research pointed to a high frequency of heart failure, accompanied by an increased risk of mortality, for patients with diabetes.

The conclusion that heart failure requires increased scrutiny, as a risk factor and complication of type 2 diabetes, has been oft quoted and researched—yet it is still not widely known how common the condition is. While microvascular effects of type 2 diabetes are well known and understood—such as neuropathy and diabetic retinopathy—and macrovascular conditions including stroke and peripheral vascular disease, heart failure almost inevitably raises mortality.

Researchers at the University of Alabama at Birmingham School of Medicine have performed series of clinical trials in an effort to determine whether or not heart failure should be more rigorously treated, in order to alleviate and mitigate the poor outcomes often seen in patients. Conclusions indicate that between 40 and 45 percent of patients with diabetes in the United States suffer from heart failure, vs. 12 percent of non-diabetes.

David S.H. Bell, MD showcased studies that specifically assessed and evaluated the complex effects of diabetes and contributing factors to the three primary causes of the heart failure, while other physicians highlighted relations between glycemic control and heart failure risk—focusing on strong correlations between the high incidence of heart failure and type 2 diabetes. Other researchers pointed to the fact that autonomic system dysfunction, a predictor of cardiovascular risk, often occurs in pre-diabetes—which might offer opportunities for early intervention. Technological advancements of the past decade currently allow for identification of the early stages of autonomic dysfunction, through the utilization of concrete, tangible standardized measurements.

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Empagliflozin FDA Approved for Prevention of Cardiovascular Death

In an unprecedented move, the US FDA approved the SGLT-2 inhibitor empagliflozin for the prevention of cardiovascular death in patients with type 2 diabetes and coexisting cardiovascular disease (CVD).

Empagliflozin was first approved in 2014 for the treatment of type 2 diabetes and later demonstrated cardiovascular risk reduction in the EMPA-REG trial. Specifically, treatment with empagliflozin significantly reduced the risk of myocardial infarction, stroke, and CV death, as well as death from any cause and hospitalization for heart failure, in more than 7000 adults with type 2 diabetes at high CV risk. Read more

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USPSTF Advises Lifestyle Counseling on CVD Prevention, Even for Low-Risk Adults

In its latest draft recommendation, the US Preventive Services Task Force (USPSTF) is advising primary care physicians to offer counseling regarding healthy lifestyle habits in preventing cardiovascular disease (CVD), even for adults who are at low risk. The recommendation applies to adults who are 18 years of age and older who are not obese, as well as adults without hypertension, dyslipidemia, diabetes, or abnormal blood glucose levels. The recommendation is a result of a review of 88 trials in which the USPSTF found that behavioral counseling provided at least a small benefit for cardiovascular risk reduction. These benefits included improvements in systolic and diastolic blood pressure levels, LDL-cholesterol levels, BMI, and waist circumference. They did not find evidence that behavioral counseling resulted in a reduction in mortality or CVD rates.

Methods of behavioral counseling included either print- or Internet-based materials and face-to-face individual or group counseling.

The USPSTF is accepting comments on the draft recommendation through January 2, 2017.

Reference:

USPSTF releases draft recommendation on behavioral counseling for healthy diet, CVD prevention.

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