CME Breakfast Symposium A · Thursday, October 25, 2018 · 6:30 – 7:45am

The Role of CGM in Individualization of T2DM Management

Faculty: Anne L. Peters, MD (Chair); Irl B. Hirsch, MD

Measuring HbA1c has been the method of choice to assess glucose control; however, this method does not reflect potential glucose excursions leading to hypoglycemia or postprandial hyperglycemia, which increase the risk of long-term complications. Self-monitoring of blood glucose (SMBG), although beneficial in glycemic control, is associated with low patient adherence. Continuous glucose monitoring (CGM) technology can circumvent some of these issues in T2DM management by providing near real-time glucose concentrations.

To maximize the utility of CGM in T2DM management, this educational activity will focus on the latest evidence-based studies, barriers, recommendations, as well as current and emerging CGM technologies aimed at maintaining glycemic goals and decreasing long-term complications of T2DM. Expert faculty will provide guidance on the applications of CGM in the professional and personal setting with the aid of video animation, as well as current and emerging CGM technologies.

Learning Objectives
After completing this activity, the participant should be better able to:

• Describe the latest published guidelines and recommendations for the use of CGM
• Review the latest evidence on the use of CGM technology in T2DM management
• Recognize new and emerging CGM technologies
• Identify how current and emerging CGM technologies can be used to improve outcomes for patients with T2DM

Supported by educational grants from Dexcom, Inc. and Medtronic.

CME Breakfast Symposium B · Thursday, October 25, 2018 · 6:30 – 7:45am

Non-Medical Switching, Barriers and Consequences

Faculty: Seth J. Baum, MD, FASPC (Chair); Kim Newlin, NP, CNS, FPCNA, FAHA

During this program, Utilization Management (UM) processes will be explored. Prior Authorization (PA) and Step Therapy will first be defined and discussed, with examples from the literature demonstrating the prevalence and consequences of these processes. The dominant part of this program will be on non-medical switching. Its definition, prevalence, healthcare burden, and health consequences will be examined. Emphasis will be on nonmedical switching in atrial fibrillation (Afib) and congestive heart failure (CHF). Related literature for all aspects of the program will be cited.

Learning Objectives
After completing this activity, the participant should be better able to:

• Understand past ASPC efforts to improve patient access to mediations
• Define the terms Utilization Management (UM), Prior Authorization (PA), step therapy, and non-medical switching
• Understand adverse consequences that can result from various UM practices, including non-medical switching
• Understand the patient’s perspective by hearing patient-stories about non-medical switching
• Understand and Utilize resources to improve patient access to prescribed medications

Supported by educational grants from Janssen Pharmaceuticals, Inc., Bristol-Myers Squibb Company, and Pfizer.

CME Lunch Symposium A · Thursday, October 25, 2018 · 12:10 – 1:25pm

Management of T2DM Patients with Diabetic Kidney Disease: Effects of SGLT2 Inhibitors and GLP-1 Receptor Agonists on Disease Progression

Faculty: Matthew R. Weir, MD (Chair); Robert D. Toto, MD; Lance Sloan, MD

Kidney disease has been recognized as a complication of type 2 diabetes mellitus (T2DM) since the 1950s, developing in approximately 35% of patients with T2DM and affecting as many as 50% of patients with diabetes of more than 20 years’ duration. The prevalence of diabetic kidney disease (DKD) in the United States increased from 1988 to 2008 in proportion to the prevalence of diabetes. Among adults with diabetes, the prevalence of DKD has remained stable despite increased use of antihyperglycemic agents and renin-angiotensin-aldosterone system (RAAS) inhibitors.

Newer glucose-lowering agents appear to have glucose-independent effects on diabetic nephropathy and its progression. Recently published analyses of secondary objectives of three key studies, EMPA-REG, CANVAS-R, and LEADER, that assessed cardiovascular outcomes of SGLT2 inhibitors and a GLP-1 receptor agonist (RA) respectively, show positive effects on the development and progression of DKD.

This symposium will utilize interactive infographics to provide an overview of the renal effects of antiglycemic agents, particularly GLP-1 RAs and SGLT2 inhibitors. Experts will identify patients who are at the greatest risk for DKD, discuss the underlying physiology of DKD, provide an overview of the mechanisms of action of SGLT2 inhibitors and GLP-1 RAs in relation to renal physiology, and how to effectively manage patients with T2DM and DKD based on the benefits and risks of SGLT2 inhibitors and GLP-1 RAs.

Learning Objectives
After completing this activity, the participant should be better able to:

• Describe the relationship between T2DM, hypertension, and cardiorenal syndrome
• Review the most current T2DM algorithms and guidelines for the individualized treatment of complex patients, specifically those with DKD
• Summarize the mode of action and effects of GLP-1 RAs and SGLT-2 inhibitors on renal physiology in patients with T2DM and DKD
• Develop management plans for T2DM patients that consider the recently discovered renal effects of SGLT2 inhibitors and GLP-1 RAs

Supported by educational grants from Janssen Pharmaceuticals, Inc., administered by Janssen Scientific Affairs, LLC. and by Boehringer Ingelheim Pharmaceuticals, Inc. and Lilly USA, LLC.

CME Lunch Symposium B · Thursday, October 25, 2018 · 12:10 – 1:25pm

Advances in HFpEF: Addressing Diagnostic and Treatment Challenges

Faculty: JoAnn Lindenfeld, MD (Chair); Keith C. Ferdinand, MD; Alanna A. Morris, MD

Prognosis and treatment of HF patients with preserved ejection fraction (HFpEF) is complicated by diagnostic challenges and complicated pathophysiologies. Compared to HF patients with reduced ejection fraction (HFrEF), HFpEF patients are generally older, more often female, and have increased metabolic comorbidities such as obesity, hypertension, and type 2 diabetes mellitus. These metabolic comorbidities are associated with an increased risk of developing HFpEF, making the increase in metabolic syndrome in the recent decades particularly concerning. The lack of specific therapies for HFpEF have contributed to the increased prevalence and prognosis of the disease, and along with complicated diagnosis and pathophysiologies, contribute to the challenges that clinicians face in managing HFpEF.

To address these clinical practice gaps, expert faculty will focus on the latest evidence-based strategies to manage HFpEF. This educational activity will also provide an overview on current and emerging resources and procedures designed to lower hospital readmission rates in HFpEF patients.

Learning Objectives
After completing this activity, the participant should be better able to:

• Employ current and emerging approaches and tools to diagnose HFpEF
• Identify current treatment guideline recommendations for HFpEF
• Recognize current gaps in the guidelines for the treatment of HFpEF
• Interpret results from clinical trials for emerging evidence-based therapies for patients with HFpEF
• Outline practices and resources aimed to improve hospital readmission rates for patients with HFpEF

Supported by an educational grant from Novartis Pharmaceuticals Corporation.

CME Dinner Symposium · Thursday, October 25, 2018 · 6:15 – 7:30pm

Mastering the Prior Authorization Process to Meet Patient Needs

Faculty: Pamela B. Morris, MD (Chair); Christie M. Ballantyne, MD; Kim K. Birtcher, PharmD; Matthew Stryker, PharmD, BCACP, CLS

The prior authorization (PA) process is often resource-intensive for medical practices. A 2016 American Medical Association (AMA) survey of physicians who regularly complete PAs found that, in combination with their staff members, the providers spent an average of 16.4 hours per week processing PAs. While estimates of the per-physician financial burden of PA and interaction with insurance companies have varied widely, all have found that those costs amount to thousands of dollars per year. One-third of the physicians in the AMA survey reported having staff members dedicated solely to PA processing, and 90% said PAs can delay a patient’s access to necessary care. In a recent survey by the American College of Cardiology (ACC) it was found that 78% of the surveyed cardiologists cited the documentation and administrative burden associated with PA to be a barrier to using newer therapies such as angiotensin receptor/neprilysin inhibitors (ARNIs), non-vitamin K antagonist oral anticoagulants (NOACs), and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.

Prior to this educational activity, an infographic overview outlining recommendations and resources for streamlining the PA process in clinical practice will be provided to learners. As part of the infographic review, learners will have the ability to submit particularly challenging patient cases associated with prior authorization or common challenges endured during the prior authorization process that will be addressed by expert faculty during the live symposium. The goal of the live symposium is to provide learners with real-life solutions and resources for streamlining the PA process in their practices, with the goal of reducing the associated burdens on healthcare providers, minimizing related stress for patients, and preserving time for direct patient care.

Learning Objectives
After completing this activity, the participant should be better able to:

• Describe the burden of the prior authorization process on physicians and staff in clinical practice and patient outcomes
• Identify strategies and resources that reduce the time and expenses associated with submissions for prior authorization
• Develop prior authorization processes to gain drug and procedure approval for patients in a timely manner

Supported by an educational grant from Sanofi US and Regeneron Pharmaceuticals and in partnership with The Doctor-Patient Rights Project.

CME Breakfast Symposium A · Friday, October 26, 2018 · 6:30 – 7:45am

The ABC Access Program: Overcoming Barriers to Access of Newer Cardiovascular Agents for High-Risk and Minority

Faculty: Keith C. Ferdinand, MD (Chair); Deirdre Mattina, MD; Catherine Davis Ahmed, MBA

Despite advances in medical therapies and new treatment modalities for patients with or at risk for cardiovascular disease, health equality and access to care remain significant areas of concern. Two associations have set their goals in addressing these clinical barriers:

The Association of Black Cardiologists (ABC) has set as its mission to address critical issues in a changing health care landscape by revealing disparities faced by minorities and high-risk patients and promulgating solutions to diminished access, especially to newer medications and therapies. The FH Foundation is dedicated to promoting the understanding of Familial Hypercholesterolemia (FH) in the medical community and public domain, examining gaps in care for those living with FH, and improving adherence to guideline-recommended treatments for FH.

During this live symposium, faculty will discuss ongoing initiatives to overcoming barriers to access, and provide overviews of both the Access to Health Care Initiative of the Association of Black Cardiologists (ABC) and the Cascade Registry from the FH Foundation. Challenging clinical patient cases will also be presented to demonstrate how to apply these solutions to real-world clinical scenarios.

After completing this activity, the participant should be better able to:

• Discuss the disproportionate burden of heart disease and stroke within the African American population and the mission of the ABC Access Initiative
• Summarize the barriers to access of quality care for African Americans and the solutions proposed in the ABC Access Initiative to improve access, especially to newer therapies
• Identify evidence-based treatment recommendations to aggressively manage cardiovascular risk factors in African Americans, thereby reducing the incidence and consequence of heart failure

Supported by an educational funding donation provided by Amgen and in partnership with the Association of Black Cardiologists, Inc (ABC).

CME Breakfast Symposium B · Friday, October 26, 2018 · 6:30 – 7:45am

Cardiovascular Risk Reduction in T2DM: Applying the Trial Data to Clinical Practice

Faculty: Robert H. Eckel, MD (Chair); Harold E. Bays, MD; Deepak L. Bhatt, MD, MPH; Lawrence Blonde, MD

Death from CV disease is 70% higher in adults with diabetes compared to those without diabetes, and patients with diabetes have a decreased life expectancy, mostly due to premature CV death. Evidence is accumulating that other factors besides impaired glucose metabolism play a role in the pathophysiology of T2DM and that a comprehensive approach against insulin resistance, obesity, hypertension, and dyslipidemia in addition to diet and exercise is required. In addition, because certain pharmacologic therapies were found to increase the risk of CV events, all new drugs introduced since 2008 have been mandated by the FDA to undergo CV safety outcome trials (CVOT) in high-risk T2DM patients. As a result, a growing body of evidence is accumulating on the effectiveness of several antihyperglycemic agents to reduce CV mortality, overall mortality, and hospitalizations for worsening heart failure in high-risk patients with T2DM.

In this symposium, experts will utilize a unique, infographic teaching format to review the latest cardiovascular outcomes studies of current antihyperglycemic therapies and compare the risks vs benefits as well as how to incorporate them into an individualized treatment plan for clinicians who treat patients with T2DM who are at a high risk for CVD.

After completing this activity, the participant should be better able to:

• Describe comorbidities of CVD among patients with T2DM, including the prevalence and burden
• Summarize current and emerging CV outcomes trials on SGLT2 inhibitors and GLP1-RAs in T2DM patients
• Incorporate evidence from recent CVOTs to develop T2DM treatment plans that improve glycemic control and reduce CV risk when appropriate based on guidelines, benefits and risks of second-line antihyperglycemic treatments, and patient profiles and preferences

Supported by educational grants from AstraZeneca and Novo Nordisk.

CME Lunch Symposium A · Friday, October 26, 2018 · 12:00 – 1:15pm

Identifying, Diagnosing and Managing Iron Deficiency in Patients with Heart Failure to Improve Outcomes and Quality of Life

Faculty: Eldrin F. Lewis, MD, MPH (Chair); Akshay S. Desai, MD, MPH; Gurusher Panjrath, MD

Iron deficiency (ID) affects up to one-third of the world's population and is particularly common in elderly individuals and those with certain chronic diseases such as chronic kidney disease, and congestive heart failure. Many of those affected are unaware of ID and cannot recognize its symptoms. For patients with heart failure (HF), ID is an independent predictor of outcomes and a major contributor to exercise intolerance. At least half of all patients with HF have comorbid ID; yet, the condition is under-recognized and untreated in most patients.

In this symposium, experts will provide participants with data from recent and ongoing trials of iron repletion in patients with HF to highlight the importance of diagnosis and proper management of this common comorbidity. Recent updates to established HF treatment guidelines that emphasize ID recognition and treatment will also be addressed. Additionally, the program will educate clinicians on the differences in oral versus intravenous iron formulations.

Learning Objectives
After completing this activity, the participant should be better able to:

• Describe the prevalence of iron deficiency (ID) in heart failure (HF) and its impact on patient outcomes and quality of life
• Identify the symptoms of ID using appropriate markers in HF patients in order to diagnose ID
• Discuss the updated ACC/AHA/HFSA recommended guidelines for the management of iron deficiency in patients with HF
• Review evidence from major clinical trials assessing the efficacy and safety of iron supplementation in HF patients to improve patient outcomes and reduce HF hospitalizations

Supported by an educational grant from American Regent.

CME Lunch Symposium B · Friday, October 26, 2018 · 12:00 – 1:15pm

New Developments in Type 2 Diabetes Treatment to Decrease the Risk of Hypoglycemia

Faculty: Robert E. Ratner, MD (Chair); Robert H. Eckel, MD; Davida Kruger, MSN, APN-BC, BCADM; Deborah J. Wexler, MD

Due to the progressive nature of type 2 diabetes mellitus (T2DM), insulin is typically initiated when patients are unable to achieve and maintain glycated hemoglobin (HbA1c) target levels with lifestyle changes and addition of one or more antidiabetic drugs to the treatment regimen. However, the initiation and intensification of diabetes treatment with insulin is often delayed in many patients due to clinical inertia and fears of hypoglycemia. Intensive insulin regimens often cause a higher risk of hypoglycemia; approximately 7% to 15% of insulin-treated patients experience at least one annual episode of hypoglycemia, and 1 to 2% have severe hypoglycemia.

During this live symposium, faculty will address the barriers to intensifying T2DM treatment with insulin, including clinical inertia and the risk of hypoglycemia, current treatment recommendations for glycemic control in T2DM, and efficacy and safety data for the newer insulin therapies and fixed-ratio combinations to achieve glycemic control and reduce hypoglycemic risk. At the conclusion of the activity, case-based, patient simulation technology will be utilized to provide learners with the opportunity to explore different decision paths and then immediately observe the consequences of their decisions—without risk. Learners will receive the benefit of engaging in deliberate practice in an environment that is safe, consistent, convenient and individualized to improve their management of patients with T2DM and risk of hypoglycemia.

Learning Objectives
After completing this activity, the participant should be better able to:

• Discuss strategies to overcome barriers to insulin intensification in T2DM, including clinical inertia and the risk of hypoglycemia
• Develop individualized T2DM therapy based on a clinical understanding of the features of oral and injectable antidiabetic medications and patient-specific needs and preferences
• Outline the safety, efficacy, and pharmacological data on new insulin therapies and fixed-ratio GLP-1RA/basal insulin combinations
• Implement patient education and patient-prescriber communication strategies to aid patients in overcoming concerns about insulin intensification and fear of injections, thus increasing patient adherence to therapy and improving clinical outcomes

Supported by an educational grant from Sanofi US.

CME Breakfast Symposium · Saturday, October 27, 2018 · 6:30 – 7:45am

Finding the Balance: Treatment and Management of Hyperkalemia in Patients with Heart Failure and Chronic Kidney Disease

Faculty: George L. Bakris, MD (Chair); Keith C. Ferdinand, MD

Hyperkalemia is a serious condition associated with increased risk of mortality and is frequently prevalent and recurrent in patients who suffer from heart failure (HF), chronic kidney disease (CKD), and/or hypertension (HTN). Comorbid illnesses and use of medicines that are important for kidney and cardiac outcomes but elevate potassium levels can also increase the chronic risk for hyperkalemia.

Although the short-term management of hyperkalemia can be very effective, the utility of current strategies to manage hyperkalemia is limited, with no long-term outcome data to guide in the management of this condition. This symposium will provide clinicians with clinical evidence on the new and potential therapies for the long-term management of hyperkalemia to improve guideline adherence and help clinicians move toward providing appropriate management for hyperkalemic patients with CKD, diabetes mellitus (DM), and/or HF by assessing risk profiles and customizing regimens based on individual patient needs.

Learning Objectives

After completing this activity, the participant should be better able to:

• Describe patient populations at the highest risk for hyperkalemia
• Assess the risk of hyperkalemia against the risk of discontinuing reno- and cardio-protective therapies based on evidence-based guideline recommendations for HF management and appropriate monitoring for renal function and hyperkalemia
• Develop appropriate treatment regimens for hyperkalemia in patients with HF and CKD based on the Identify the efficacy, safety, and mechanisms of action of current and emerging therapies

Supported by an educational grant from Relypsa, Inc.