LEADER Will Be Star of Show at ADA in the Big Easy, but Much More

Miriam E Tucker

June 03, 2016

The Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results — A Long Term Evaluation (LEADER) trial results will top the headlines from this year's American Diabetes Association (ADA) 2016 Scientific Sessions, but of course there will be much, much more.

At the meeting, to be held here June 9–14 in New Orleans, Louisiana, many are hotly anticipating the detailed results of the multicenter, international trial.

In March 2016, company officials announced top-line results indicating that the glucagonlike peptide 1 (GLP-1) receptor agonist liraglutide (Victoza, Novo Nordisk), used to treat type 2 diabetes, significantly reduced the risk of major adverse cardiovascular events but gave no further information.

"It's a class of drugs, the [glucagonlike peptide-1] GLP-1 receptor agonists, for which there is until now no definitive evidence one way or another on long-term outcomes being favorable," ADA program chair Matthew C Riddle, Jr, MD, professor of medicine in the division of endocrinology, diabetes, and clinical nutrition at Oregon Health Sciences University, Portland, told Medscape Medical News.

And Desmond Schatz, MD, ADA's president, medicine & science, noted: "We're obviously concerned there's a high mortality in diabetes, and cardiovascular disease is a leading cause of death. Any drug that can decrease cardiovascular events will certainly be a major finding."

Of course, there will be much, much, more at the meeting, including a huge array of diabetes-related topics covered in more than 100 symposia, workshops, and special award lectures, along with over 2500 oral and poster presentations of new data.

A special 1-day program on Saturday will target primary-care providers, and a 2-day program starting Thursday will aim to help early-career diabetes professionals.

In all, more than 16,000 attendees from around the world are expected to attend over the 5 days.

"The ADA meetings are the largest and arguably the most-awaited diabetes meetings of the year….This year, there will be more non-US attendees than from the US, so it's not just American. It's really a global meeting," Dr Riddle said.

Underscoring the reason for all the attention will be Dr Schatz's presidential address on Sunday, "Diabetes at 212 Degrees — Confronting the Invisible Disease."

Using the metaphor of water's boiling point, "I will highlight invisibility of the disease to the public, the growing epidemic, and most important the need for urgency.…We haven't yet cured or prevented diabetes, and it's spiraling out of control.…We need to raise awareness. I will be challenging the audience repeatedly throughout the talk."

LEADER and EMPA–REG

On Monday afternoon, an entire 2-hour symposium will be devoted to the LEADER trial, which began in 2010 and enrolled over 9000 type 2 diabetes patients who were randomized to liraglutide or placebo, on top of usual care. The results are expected to be simultaneously published in a major journal.

Dr Riddle contrasted the expected LEADER findings to those of another similar trial of a GLP-1 agonist, the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study, presented at last year's ADA meeting.

"ELIXA was a shorter-term study in very high-risk patients, and the results were neutral. It speaks to safety rather strongly, but not to long-term benefit. LEADER is a longer study and apparently does show a favorable effect, so that's very big."

Dr Riddle also pointed to the importance of another 2-hour symposium at this year's ADA meeting on Tuesday morning on the (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG), the results of which were presented in September 2015 at the European Association for the Study of Diabetes conference and also published in the New England Journal of Medicine.

EMPA-REG, involving more than 7000 high-risk patients randomized to empagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, or placebo, on top of usual care, showed — for the first time with a type 2 diabetes medication — a 14% reduction in major adverse cardiovascular events, including a 38% reduction in cardiovascular death. At this ADA meeting, new data will be presented on both macrovascular and microvascular secondary end points and a "mediation analysis" will be described, exploring possible underlying mechanisms for empagliflozin's effects.

"EMPA-REG really startled people because it had such a strong favorable outcome in a very high-risk population. The cardiology community had almost given up on seeing any cardiovascular benefit from a glucose-lowering drug….I think that's of equal interest to LEADER. Everyone is very interested in the SGLT-2 blockers and really wants to know why the results were so good," Dr Riddle said.

Indeed, he added, "Now we have two classes of [glucose-lowering] drugs with cardiovascular benefit. The reason it matters so much is there are large groups of the medical community who think treating diabetes really is irrelevant from the point of view of heart disease.

"The cardiology community and the primary-care community have taken a skeptical view in some cases as to whether glucose control really matters in terms of heart outcomes."

Top Abstracts

As usual at the ADA meeting, from thousands of abstracts submitted, the top eight will be presented Tuesday morning in the "ADA Presidents Oral Session," cochaired by Dr Schatz and ADA's Health Care & Education president Margaret A Powers, PhD, RD, CDE.

The more clinical of these this year include:

  • Cumulative Life Stress Is Associated With Islet-Cell Autoimmunity in HLA DR3/4 Children.

  • Brain Gray-Matter Volume Changes in Youth With Type 2 Diabetes.

  • Closed-Loop Glucagon Administration for the Automated Prevention and Treatment of Hypoglycemia in Type 1 Diabetes.

  • Physical Activity and Diabetes Development: The Diabetes Prevention Program Outcomes Study.

  • Diabetes Prevention With Pioglitazone in Insulin-Resistant Patients With Cerebrovascular Disease.

The abstract content will be posted at 5:00 pm Friday June 3. "All are superb presentations," Dr Schatz promised.

Follow the Money

Not surprisingly, several sessions at the meeting will tackle the cost of medicines in the United States, the difficulties people with diabetes encounter in obtaining their medications and receiving appropriate care, and the issues physicians face in the new era of value-based payment systems.

"How can health systems deal with the costs of diabetes? How can people with diabetes best navigate their way to affording health insurance and getting the specialty care they need? These are terribly important from a clinical point of view," Dr Riddle commented.

In a symposium on Friday entitled "Follow the Money—How Costs and Payments Impact Diabetes Care," four speakers will address the price of diabetes care, drug pricing, insurance contracting, and value-based reimbursement, respectively.

Another symposium, on Monday, "Risk-based Contracting—Preparing for the Inevitable," will take an in-depth look at the new payment models, with speakers addressing the policy rationale/implications and the perspectives of academic medical centers, the healthcare system, and private insurers.

Dr Riddle said, "I think these symposia are important because they will explain the relationship between the clinician, the health systems in which they work, the pharmacy benefit managers, the insurers, and the manufacturers of the products….We hope the sessions will help the doctors understand the decisions that are being made within the organizations where they work."

And an oral abstract session on Saturday, "At What Cost? Assessing the Financial Impact of Care Models, Co-Pays, and Complications in Diabetes," will feature new data on diabetes-related medical expenditures and models of care that could potentially ease the burden.

Dr Schatz noted that ADA is currently investigating the cost of insulin "and looking at further action to make insulin available to all our patients."

Other Hot Topics

As they do every year, the award lectures will feature some of the hottest scientific topics in diabetes research.

These include the Banting Medal talk on Sunday morning, "Adipose Tissue, Inter-Organ Communication, and the Path to T2D," by Barbara B Kahn, MD, of the Joslin Diabetes Center, Boston, Massachusetts, and the Kelly West Award lecture Sunday afternoon, "The Changing Tides of the Diabetes Epidemic — Smooth Sailing or Troubled Waters Ahead?" by Edward W Gregg, PhD, of the Centers for Disease Control and Prevention, Atlanta, Georgia.

Dr Riddle said that Dr Kahn's Banting lecture "will be even better this year than usual," adding, "She's a great speaker and it's such an important issue — We don't understand why so many people around the world are getting heavier and getting more diabetes and vascular disease. She's going to report on several decades of work. It will be quite important."

In all, Dr Schatz said, the ADA's 2016 Scientific Sessions will be "a very exciting, very big meeting….Hopefully we can raise awareness and create a sense of urgency."

Dr Riddle has received research support from AstraZeneca, Biodel, GlaxoSmithKline, Eli Lilly, Sanofi, and Valeritas. Dr Schatz has no relevant financial relationships.

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