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Guidelines Updates in Diabetes and Cardiovascular Disease

Mary Caffrey
A statement on hypoglycemia, an consensus document from cardiologists on diabetes and CVD, and guidelines on treating cholesterol.
ADA/EASD Release Joint Statement on Managing Hyperglycemia in Type 2 Diabetes

Ongoing access to diabetes self-management education and support (DSMES) and promoting good medication adherence are among the keys to managing hyperglycemia, or high blood glucose, in patients with type 2 diabetes (T2D), according to a joint statement from the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), released

October 5, 2018, at the EASD annual meeting in Munich, Germany.

The consensus statement also called for patients with cardiovascular disease to be treated with 1 of the 2 novel classes that have been shown to have cardiovascular benefits: a sodium-glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist.

The statement was published in Diabetologia,1 the official journal of EASD, and in Diabetes Care, the official journal of ADA. The joint statement followed ADA’s recommendations in late 2017 that certain SGLT2 inhibitors and a GLP-1 receptor agonist had cardiovascular benefits; these recommendations appeared in the organization’s 2018 Standards of Medical Care in Diabetes.2

The experts who developed the ADA/EASD consensus statement said that patient preference should be a major factor in driving treatment choices, because their preferences for the delivery method—such as a pill versus an injection—or things like adverse effects or cost, could affect adherence. Further, the medications cannot work if patients do not take them, regardless of what evidence showed in a clinical trial.

The emphasis on giving patients more access to DSMES is key, because current reimbursement models, including those in Medicare, may limit the number of hours or points at which a patient can meet with a diabetes educator.

Although there are new digital diabetes management tools available, evidence shows that these work best when patients can combine them with contact with a trained professional.3 A position statement from the American Association of Diabetes Educators, ADA, and the Academy of Nutrition and Dietetics called for education at discrete points in the life cycle of diabetes: (1) at diagnosis, (2) at annual assessments, (3) when new complications occur, and (4) during transitions in life and care.4

Among other recommendations, the ADA/EASD consensus statementcalls for:

• Advising patients who are overweight or obese with diabetes to start a lifestyle management program, including food substitution where appropriate.

• Boosting physical activity to improve glycemic control.

• Making metabolic surgery available to adults with T2D who have a body mass index (BMI) of at least 40 (or ≥37.5 with Asian ancestry) or a BMI of 35 to 39.9 (32.5-37.4 with Asian ancestry) who have comorbidities and have not achieved weight loss goals with nonsurgical methods.

• Metformin continues to be the first-line therapy, but for patients with clinical cardiovascular disease, an SGLT2 inhibitor or GLP-1 receptor agonist with a demonstrated cardiovascular benefit is recommended.

• For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefits should be considered.

• GLP-1 receptor agonists are the first injectable considered, except if type 1 diabetes is a possibility.

Experts called for more research into combinations of glucose-lowering therapies. “As cost implications for these various approaches is enormous, evidence is desperately needed,” the panel said in a statement. “Defining optimal cost-effective approaches to care, particularly in the management of patients—including those with multi-morbidity—is essential.”5

The panel said the giant cardiovascular outcomes trials raise important questions: Do benefits, including renal benefits, extend to low-risk patients? If so, for which population groups?

Shortly after the joint statement, an FDA advisory panel agreed to continue the cardiovascular outcomes trials that have demonstrated unexpected cardiovascular benefits in T2D (see Cover). However, the panelists discussed the possibility of making adjustments to the trials to examine different outcomes and to bring down their cost. Since the emergence of unanticipated benefits in newer therapeutic classes for T2D—notably SGLT2 inhibitors—some pharmaceutical companies have launched trials to specifically examine heart failure or renal outcomes.6-8

“The management of hyperglycemia in type 2 diabetes has become extraordinarily complex with the number of glucose-lowering medications now available,” the authors wrote. “Patient-centered decision making and support and consistent efforts to improve diet and exercise remain the foundation of all glycemic management. Initial use of metformin, followed by addition of glucose-lowering medications based on patient comorbidities and concerns is recommended as we await answers to the many questions that remain.” 


References

1. Davies MJ, D’Alessio DA, Fradkin J, et al. Management of hyperglycaemia in type 2 diabetes, 2018. a consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2018; 61(12):2461-2498. doi: 10.1007/s00125-018-4729-5.

2. Caffrey M. ADA 2018 standards address dugs with CV benefits, hold firm on blood pressure. The American Journal of Managed Care® website. www.ajmc.com/newsroom/ada-2018-standards-address-drugs-with-cv-benefits-holdfirm-on-blood-pressure. Published December 10, 2017. Accessed December 2, 2018.


3. Gabbay R. In the era of payment reform, diabetes educators can lead the way toward value-based care. Am J Manag Care. 2018;24(SP11):SP448.

4. Powers MA, Bardsley J, Cypress M, et al. Diabetes self-management education and support in type 2 diabetes: a joint position statement of the American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics. Diabetes Care. 2015;38(7):1372-1382. doi: 10.2337/dc15-0730.

5. New EASD-ADA consensus guidelines on managing hyperglycaemia in type 2 diabetes launched at EASD meeting. new recommendations include specific drug classes for some patients and enhancing medication adherence. Diabetologia website. http://diabetologia-journal.org/2018/10/05/new-easd-ada-consensus-guidelines-onmanaging?rel=0" -

hyperglycaemia-in-type-2-diabetes-launched-at-easd-meeting-new-recommendations-includespecific-drug-classes-for-some-patients-and-enhancing-medication-a. Published October 5, 2018. Accessed October 8, 2018.

6. Evaluation of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Participants With Diabetic Nephropathy (CREDENCE). ClinicalTrials.gov website. clinicaltrials.gov/ct2/show/NCT02065791. Published February 19, 2014. Updated November 19, 2018. Accessed December 3, 2018.

7. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Reduced Ejection Fraction (EMPEROR-Reduced). ClinicalTrials.gov website. clinicaltrials.gov/ct2/show/NCT03057977. Published February 20, 2017. Updated November 27, 2018. Accessed December 3, 2018.

8. EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). ClinicalTrials.gov website. clinicaltrials.gov/ct2/show/NCT03057951. Published February 20, 2017. Updated November 27, 2018. Accessed December 3, 2018.


ACC Pathway Finds Empagliflozin “Preferred” SGLT2 Therapy for Patients With Type 2 Diabetes, ASCVD

A new American College of Cardiology (ACC) Expert Consensus Decision Pathway states that empagliflozin is the preferred therapy among sodium-glucose cotransporter 2 (SGLT2) inhibitors for patients with type 2 diabetes (T2D) and atherosclerotic cardiovascular disease (ASCVD).

The pathway document, which features a chart to guide cardiologists in clinical practice, was published November 26, 2018, in the Journal of the American College of Cardiology (JACC).1 The consensus document also finds that liraglutide is the preferred treatment among a second novel class of T2D treatments, the glucagon-like peptide-1 (GLP-1) receptor agonists.

Empagliflozin is sold as Jardiance by Boehringer Ingelheim and Eli Lilly; liraglutide is sold as Victoza by Novo Nordisk. Although cardiovascular disease remains the leading cause of morbidity and mortality in patients with T2D, the authors write that, until recently, medications to achieve glycemic control were not expected to offer any cardiovascular benefit. “The recent development of [2] novel classes of therapies—SGLT2 inhibitors and GLP-1 [receptor agonists]—has, for the first time, demonstrated that treatments developed for glucose lowering can directly improve outcomes,” wrote Writing Committee co-chairs Sandeep R. Das, MD, MPH, FACC; Brendan M. Everett, MD, MPH, FACC; and their colleagues.

Having ACC weigh in on how cardiologists should treat patients with T2D represents a paradigm shift in treating the disease, but one that is a natural evolution given developments since 2015 in research, treatment, and guidelines from major organizations engaged in diabetes care. Having ACC weigh in on how cardiologists should treat patients with T2D

represents a paradigm shift in treating the disease, but one that is a natural evolution given developments since 2015 in research, treatment, and guidelines from major organizations engaged in diabetes care.

On October 5, 2018, the American Diabetes Association (ADA) and the European Association for the Study of Diabetes jointly updated their consensus statement on

the management of hyperglycemia to include SGLT2 inhibitors and GLP-1 receptor agonists.ADA endorsed the ACC pathway, and William T. Cefalu, MD, ADA’s chief

scientific, medical, and mission officer, served as an author on the JACC article.

Thomas Seck, MD, vice president of US Clinical Development and Medical Affairs, Primary Care, at Boehringer Ingelheim, shared the authors’ appreciation for the change in thinking about shared responsibilities of cardiologists and primary care physicians in diabetes care: “This is an important milestone—it underscores the important change we’ve seen in the last few years,” as guidelines have changed to reflect new evidence, he said in an interview with The American Journal of Managed Care®. “There are now multiple options for patients with [T2D] and established cardiovascular disease, and that’s critically important.”

For ACC to put the cardiologist in charge of management of cardiovascular risk for a patient with T2D is a major step forward, Seck said. “Before, diabetes was about managing glucose, and the cardiologist was much less involved,” he said.

 
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