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CMHC PULSE

Cardio Metabolic Health Congress – Official Blog

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

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.