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Month: August 2015

Cardiometabolic Think Tank Releases New Patient Care Model for Metabolic Syndrome

A new, integrated patient care model has been developed based on consensus recommendations from a Cardiometabolic Think Tank that will accurately identify patients at risk for metabolic syndrome before it develops and recognizes subtypes and stages of metabolic syndrome, to more effectively direct prevention and therapies. The Cardiometabolic Think Tank, organized by the CardioMetabolic Health Alliance, convened in June 2014 as a “call to action” to define new patient care models and approaches to address various issues related to cardiometabolic risk and disease.

According to consensus from the Think Tank, metabolic syndrome is progressive, associated with serious and extensive comorbidity, but is often clinically underrecognized. Implementing the new care model will require: Read more

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First Fully Mobile Continuous Glucose Monitor Gets FDA Approval

The US FDA has just approved the first and only fully mobile continuous glucose monitoring system for both adults and children as young as 2 years of age. The system sends glucose information in real time directly to an app on iOS-enabled devices, such as the iPhone, using Bluetooth technology. (Android applications are expected early next year.) The Dexcom G5 Mobile CGM System allows for up to 5 “followers,” such as parents or other caregivers, to remotely monitor the patient’s glucose levels and receive alerts about readings of concern.

To learn more on innovations such as these, join us at #CMHC 2015 on Saturday, October 24 for “Advances in Diabetes Technology,” to be presented during the Diabetes Management session by expert faculty speaker Anne L. Peters, MD.

Read more here.

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AHA/ADA Updates Scientific Statement on CVD Prevention for Patients with Type 2 Diabetes

In an update to their previous 2007 statement, the AHA and ADA recently presented a review of the current literature and key clinical trials regarding blood pressure and glucose control, cholesterol management, aspirin therapy, and lifestyle modification for primary prevention of CVD in patients with type 2 diabetes. Both the AHA and ADA believed an update was in order due to the major changes that have occurred in the past several years in each of the “ABC” elements of diabetes care (HbA1c, blood pressure, and cholesterol), and because CVD remains the leading cause of death among patients with type 2 diabetes. Read more

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As PCSK9 Inhibitors Come to Market, Concern Over 2013 Guidelines Resurfaces

Now that the first PCSK9 inhibitors have received FDA approval, the ambiguity of the 2013 ACC/AHA cholesterol-treatment guidelines are again being called into question. Because the new class of LDL-lowering agents are expensive specialty medications, with alirocumab priced at about $14,600 per year, payers are expressing concern that the removal of specific LDL-C targets from the 2013 guidelines will complicate treatment choices and inhibit utilization management tools, such as step therapy and prior authorization, to manage costs. Consequently, they are asking the American College of Cardiology and American Heart Association to return specific LDL targets to the guidelines.

In a recent publication in the European Heart Journal, however, Drs. Jennifer G. Robinson and Neil J. Stone explain the concept of net benefit, which was introduced in the 2013 ACC/AHA guidelines, and how net benefit can be used to identify patients most likely to benefit from statin therapy and which patients may benefit from the addition of a non-statin agent, such as ezetimibe or another LDL-lowering medication. Read more

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Two New Balloon Devices Approved for Obesity Treatment

Two new minimally invasive obesity devices have been granted FDA approval in the battle to achieve weight loss: ReShape™ and ORBERA™ balloon systems are temporarily implanted in the stomach and then filled with saline via endoscopic procedures that take less than 30 minutes and require only mild sedation. Both devices are designed to be left in place for 6 months and work by causing the patient to feel a sense of fullness without altering the natural anatomy of the stomach. ReShape consists of dual balloons that are filled and sealed separately and is indicated for obese adults having a BMI of 30 to 40 kg/m2 with one or more obesity-related conditions. ORBERA consists of a single balloon and is indicated for obese adults with a BMI of 30 to 40 kg/m2 who have been unable to lose weight through diet and exercise alone. Patients receiving either device should continue to participate in a diet and exercise program.

The balloon systems are the second and third devices to be approved in 2015 (Maestro [EnteroMedics], an electrical stimulator that works by blocking nerve activity between the brain and stomach, was approved in January), after a period of several years with no approvals.

For more on the latest developments in obesity management, the Lifestyle and Obesity Management session being held at #CMHC2015 on Friday, October 23, will include a comprehensive look at the “Long-Term and Metabolic Effects of Bariatric Surgery,” presented by faculty experts Lee M. Kaplan, MD, PhD, who was director of the recent FDA workshop on device development for obesity and metabolic diseases, and Francesco Rubino, MD, whose work helped transform bariatric surgery from a mere weight loss therapy to one intentionally aimed at treating diabetes and other metabolic illnesses.

 

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Antisense Inhibitors of ApoC3 and Lp(a) Show Positive Results in Phase 1 and 2 Studies

In a Phase 2 trial, patients with very high to severely high triglycerides who were treated with the investigational drug, volanesorsen (Akcea Therapeutics), a second-generation antisense inhibitor of apolipoprotein C-III (ApoC3) synthesis, achieved mean reductions of up to 80% in ApoC3 and up to 71% in triglycerides. HDL-C levels increased, on average, up to 46%. The trial was double-blinded, randomized, placebo-controlled, and conducted over 13 weeks to assess the safety and activity of volanesorsen as monotherapy and as an add-on to fibrates. Phase 3 study (APPROACH) is ongoing in patients with familial chylomicronemia syndrome (FCS) and another Phase 3 study is planned for later this year in patients with familial partial lipodystrophy (FPL). Read more

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Proposed Quality Measure Will Ensure African Americans with Heart Failure Receive the Standard of Care

A new quality measure has been submitted for consideration by the National Minority Quality Forum (NMQF) to the National Quality Forum (NQF), that if approved, will help ensure that African Americans living with heart failure (HF) will not die prematurely because they are not receiving the standard of care. Public comment began on July 23 and members of the general public are encouraged to support the proposal and comment by August 12 via the NQF’s webpage.

This past March, Dr. Keith C. Ferdinand spoke on the prevalence and severity of HF in African Americans at the Best of the CMHC Regional Conference Series.

“The harsh reality is that African Americans suffer from earlier onset and more prevalent and severe heart failure, with higher readmissions,” Dr. Ferdinand said. “These real and unfortunate disparities demand the appropriate application of evidence-based, guideline-supported pharmacotherapy in blacks. Clinicians, public health leaders, and policymakers cannot overlook this necessary responsibility to ensure the best therapy for all patients where indicated.” Plan on attending the 10th Annual CMHC Boston, October 21-24, 2015 to hear more perspective on the topic.

The new quality measure is fully supported by the Association of Black Cardiologists as well as ACC/AHA guidelines and emphasizes the importance of adherence to the current standard of care for African Americans with HF. More than 550,000 African Americans are living with HF, of whom more than 150,000 should be prescribed fixed-dose hydralazine and isosorbide dinitrate, a drug regimen proven to reduce mortality in African Americans by 43% and first-time hospitalizations for HF by 33%.

Few, however, are actually receiving this regimen. According to Dr. Gary Puckrein, CEO of the NMQF and the proposed measure’s steward, “Astonishingly, only a very small portion, about 7%, of African Americans who are clinically eligible for the therapy are getting it.”

View Dr. Keith Ferdinand’s One-Minute Clinician video interview for more insight.

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