Conference Stories That Captivated AJMC® Readers in 2017

Samantha DiGrande

In 2017, The American Journal of Managed Care® (AJMC®) covered conferences on a range of topics: oncology, diabetes, managed care, and much more. however, the most-read coverage from conferences that AJMC® attended mostly focused on cardiology trial results, particularly the cardiovascular results of diabetes medications.

Here are our biggest conference coverage hits from 2017:

5. Emotional Dysregulation and Executive Dysfunction in Patients With ADHD and Bipolar Disorder.
David W. Goodman, MD, FAPA, of Johns Hopkins School of Medicine and the director and founder of the Adult Attention Deficit Disorder Center of Maryland, presented a session on distinguishing bipolar disorder and attention-deficit/hyperactivity disorder (ADHD) during the 2017 Neuroscience Education Institute Congress. Goodman began the session by providing statistics on the prevalence of ADHD and bipolar disorder in both children and patients in the United States. He explained that many of the symptoms for the 2 disorders overlap.

“Where emotional dysregulation used to be part of the bipolar mood disorder arena, we now understand it to be part of ADHD as well,” said Goodman. “And the cognitive problems and the executive function, which were subsumed under ADHD, are now understood to be part of bipolar disorder, major depression, and a variety of other psychiatric disorders.”

Emotional regulation causes several social impairments for patients, including a low threshold for emotional excitability/impatience, behavioral dyscontrol in the face of strong emotions, and an inflexibility/slow return to baseline.

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4. Dr Jim McDermott Discusses Objectives and Outcomes of CVD-REAL Trial
The CDV-REAL study was presented at the American College of Cardiology (ACC)’s 66th Scientific Session asked whether the cardiovascular (CV) effects of sodium glucose co-transporter-2 (SGLT2) inhibitors in a real-world environment (RWE) setting with a broad patient population, according to AstraZeneca’s Jim McDermott, vice president for Medical Affairs, Diabetes. It is the first large RWE study looking at patients with type 2 diabetes, looking at the all-cause mortality, hospitalization for heart failure, comparing SGLT2s to other glucose-lowering drugs.

The purpose of the study was 3-fold: to see if, following the results of EMPA-REG, the hospitalization for heart failure was actually a class effect for SGLT2 agents, to see if these effects were seen in a broader patient population, and to determine if this was applied to a real-world setting.

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3. CANVAS Finds Lower Risk of CV Events for Invokana
According to a presentation at the 77th Scientific Sessions of the American Diabetes Association, findings from a 10,000-person trial reported that canagliflozin (Invokana), the SGLT2 sold by Janssen, offers patients with type 2 diabetes a reduced risk of CV events and decline in kidney function. The CANVAS and CANVAS-R studies simultaneously appeared in the New England Journal of Medicine (NEJM) and reported that canagliflozin demonstrated CV safety.

In addition, the components of the primary outcome—death from CV causes, nonfatal heart attack, and nonfatal stroke—were all lower with the drug. In 2008, when the FDA directed companies to perform CV outcomes trials for new diabetes and obesity therapies, the idea was to rule out harmful effects for high-risk patients; there was no expectation that diabetes drugs would prevent heart attacks or early death. Since EMPA-REG OUTCOME, however, the possibility that the entire SGLT2 class may offer these benefits prompted Merck and Pfizer to expand the VERTIS CV trial for its investigational therapy, ertugliflozin, which has an FDA approval deadline sometime this month.

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2. Low-Dose Xarelto Beats Aspirin for Long-Term Prevention of Life-Threatening Blood Clots
This study, known as EINSTEIN-CHOICE, was the first head-to-head trial to compare 2 common options for treatment to prevent recurrent venous thromboembolism (VTE). For patients who have experienced a life-threatening blood clot, taking a low dose of the anticoagulant rivaroxaban, sold as Xarelto, reduced the risk of a recurrence by 70% compared with aspirin according to the study.

Results of the study, published in the NEJM, were presented at the ACC’s 66th Scientific Session of the in Washington, DC. Findings showed that rivaroxaban could be used to treat patients at risk for recurrent VTE, without significant risk of bleeding. Research is currently underway to determine the cost-effectiveness of managing VTE patients with rivaroxaban.

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1. Can SGLT2 Inhibitors Prevent Heart Failure in a Broad Population?
Results from the CVD-REAL study were presented at the ACC’s 66th Scientific Session. The study, which covered patients from the United States and 5 European countries, examined questions left unanswered by the EMPA-REG OUTCOME study, which was the first cardiovascular outcomes trial (CVOT) that did not just find that a type 2 diabetes therapy was safe, but that it could offer cardioprotective benefits and reduce deaths, as well.

CVD-REAL is scheduled to continue with not only the United Sates participating, but Denmark, Norway, Sweden, the United Kingdom, and Germany; with future studies potentially including data from Canada, Mexico, and Japan. The expense of CVOTs has raised the question whether data-driven studies, such as CVD-REAL, could be the way of the future.

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