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Month: July 2016

GLP-1 Receptor Agonist Lixisenatide Approved by US FDA

The GLP-1 receptor agonist lixisenatide has received US FDA approval for the treatment of adults with type 2 diabetes as an adjunct to diet and exercise. Approval was based on 11 clinical trials that evaluated more than 11,000 patients, including a cardiovascular outcomes trial, ELIXA, that showed no increase in adverse cardiovascular events. Efficacy studies showed lixisenatide improved HbA1c when used alone and in combination with other therapies, including sulfonylureas, metformin, pioglitazone, and basal insulin.

Lixisenatide will be available in a disposable prefilled pen.

Reference: Medscape Medical News. GLP-1 agonist lixisenatide okayed for type 2 diabetes in US.

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Keynotes Announced for 11th Annual CMHC!

Boston, July 22, 2016––The Cardiometabolic Health Congress has announced 5 Keynote presentations have been scheduled for the 11th Annual CMHC, taking place October 5-8, 2016, at the Sheraton in Boston, MA. The 3 ½-day event has become the largest US-based, multidisciplinary conference focused solely on the prevention, diagnosis, and management of cardiovascular and metabolic diseases.

The increased number of Keynotes for this year’s Annual Meeting will address the growing areas of cardiometabolic disease management and are as follows: Read more

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Medical Schools Are Still Largely Ignoring Nutrition Education, Leaving HCPs to Take Their Own Initiative

Despite the well-known fact poor nutrition is a major contributing risk factor for chronic diseases, medical schools are still failing to adequately prepare healthcare professionals for nutrition challenges in clinical practice.

It has become a well known fact that poor nutrition and lifestyle choices play a large role in the development of most chronic conditions, including cardiovascular and metabolic diseases – and cardiometabolic conditions such as diabetes and obesity continue to accelerate at an alarming pace. Yet, the teaching of nutrition in most US medical schools has been recognized for decades as being inadequate. How can healthcare professionals (HCPs) effectively treat their patients without proper education to recognize and treat the nutritional root causes? Read more

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ACC Releases Guidance on Role of Nonstatin Therapies for LDL-C Lowering

The American College of Cardiology (ACC) has released guidance on the role of nonstatin therapies in the lowering of LDL cholesterol, as additional data on their use have become available since the ACC and American Heart Association (AHA) last updated the cholesterol guidelines in 2013. According to Donald M. Lloyd-Jones, MD, Northwestern University Clinical and Translational Sciences Institute, and Chair of the document’s writing committee, the goal of this latest guidance is to assist clinicians in interpreting the newest data for use in clinical practice and help guide their patients in making treatment decisions.

Seven different algorithms were produced for patients with cardiovascular disease or comorbidities and recommends the consideration of nonstatin drugs for patients at high risk whose LDL has not been reduced by 50% with lifestyle and statin therapy. The algorithms endorse the four evidence-based statin benefit groups already identified in the 2013 ACC/AHA cholesterol guidelines and assume the patient is taking a statin or has attempted statin therapy. Two different algorithms were created for patients with familial hypercholesterolemia (FH) and recommend a lower threshold for the use of PCSK9 inhibitors. Read more

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Are We Any Closer to Understanding What’s Driving the Cardiovascular Benefits Seen in EMPA-REG?

Theories abound on what’s driving the cardiovascular benefits seen in EMPA-REG, as an FDA advisory panel votes to support a claim of CV risk reduction on the SGLT-2 inhibitor empagliflozin’s label.

An advisory panel to the US FDA has voted, albeit narrowly, to allow the claim that treatment with the SGLT-2 inhibitor epagliflozin reduces the risk of cardiovascular death in patients with type 2 diabetes. Results of EMPA-REG, which were published last year, showed that the drug reduced cardiovascular death by 38% and reduced the combined risk of cardiac death, non-fatal myocardial infarction, and non-fatal stroke by 14%. The potential mechanisms by which empagliflozin works to reduce this cardiovascular risk are still not known, however, and were the focus of discussion at the recent ADA 2016 Scientific Sessions.

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Update and Clinical Implications of the SPRINT Trial

The SPRINT trial created both excitement and controversy in the medical community when it was realized aggressive blood pressure lowering to a target of 120 mmHg resulted in significant reductions in cardiovascular events and all-cause mortality. These reductions were seen in all of SPRINT’s subgroups including those older than age 75, persons with previous CAD, and those with chronic kidney disease. In her Keynote presentation, “Update and Clinical Implications of the SPRINT Trial,” Suzanne Oparil, MD, one of the principal investigators of the trial, will discuss the benefits seen in SPRINT as well as its caveats while touching on some of the ongoing substudies, including a cost-effectiveness analysis and a mind outcomes study examining the question of whether aggressive blood pressure lowering preserves cognitive function and brain structure.

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Triglycerides on the Rise: Should We Swap Seats on the Seesaw?

Although we may be entering an era of waning cardiovascular risk attributable to LDL cholesterol, the recurrent event rate even with the best of current therapies remains unacceptably high. In his Keynote presentation, “Triglycerides on the Rise: Should We Swap Seats on the Seesaw?” Dr. Peter Libby will discuss the increasing prevalence of other cardiovascular risk factors, including triglycerides and specifically, the apolipoprotein constituent of many triglyceride-rich lipoproteins, apoC3. According to Dr. Libby, “We have a growing need for novel therapies that address the global shift in the risk factor profile we currently confront. Treatments that target triglyceride-rich lipoproteins, inflammation, diabetes, obesity, and other contributors to residual risk in the statin era now urgently require rigorous assessment in clinical trials.”

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The Gut Microbiome as a Modifier of Insulin Resistance and Metabolic Syndrome

It is known that diabetes, obesity, and metabolic syndrome are the result of gene/environment interactions but a newly recognized component of the gene/environment interaction is the gut microbiome. In the Keynote presentation, “The Gut Microbiome as a Modifier of Insulin Resistance and Metabolic Syndrome,” Dr. Ronald Kahn will discuss results of his research in mice which have shown that given different diets, different mice adapt with different microbiomes, some of which are more or less likely to produce insulin resistance and the metabolic syndrome. Thus, the microbiome interacts with the genetics of the mouse, and by shifting the microbiome, a mouse genetically at the borderline of becoming insulin resistant, for example, may become less insulin resistant. Dr. Kahn will explain how the gut microbiome is an important mediator of the gene/environment interaction, some of the mechanisms by which the gut microbiome works, and ultimately what the implications are in terms of how we treat patients.

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Obesity Fat Distribution and Cardiovascular Risk

The ever-increasing obesity epidemic has placed that risk factor at the front of cardiovascular disease risk assessment and management. But specifically, how does body fat distribution impact cardiovascular risk? In the Keynote presentation, “Obesity Fat Distribution and Cardiovascular Risk,” Dr. Subodh Verma will evaluate the epidemiology and clinical course of visceral fat as it relates to cardiovascular event rates and explain the mechanistic basis of how visceral adiposity leads to cardiovascular disease. Additionally, Dr. Verma will shed light on the role of epicardial fat tissue as a source of inflammatory cytokines in cardiometabolic risk, critique the literature linking weight reduction to cardiometabolic risk reduction, and discuss the current guidelines for the management of cardiovascular risk in obesity.

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