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Evidence-Based Diabetes Management December 2017

Eldrin F. Lewis, MD, MPH, on Heart Failure's Place in Diabetes Drug Trials, and the Promise of SGLT2s in Prevention

Mary Caffrey
The payment reform movement has changed the thinking about what can be done for patients with diabetes and heart failure, for the good of patients.
LEWIS: There will be challenges—payer restrictions are problematic. The tricky part is, it’s hard to know whether we’re receiving them early enough because we don’t have enough trials to inform us about the timing and the impact of the tiered approach. Metformin still becomes the foundation of diabetes management. Most primary care physicians and endocrinologists would start metformin first. There hasn’t been a head-to-head trial that asks, “In newly diagnosed diabetes, should we start metformin or an SGLT2 inhibitor?” Once we have that information, it will be easier to go away from the current guidelines. The guidelines say, “Start with metformin and then expand.”

In terms of restrictions—and I don’t have data, this is strictly my opinion—if you have a prior authorization that is required, a busy clinician will often find that hurdle somewhat challenging. You have to slow down, complete the form, and sometimes have to do a peer-to-peer review, which takes additional time. If you’re a busy clinician, it becomes challenging in between seeing your 45 to 50 patients. Prior authorization can be enough of a hurdle to reduce utilization.

Unfortunately, we don’t have primary data that evaluate primary care clinicians on why they haven’t started a new therapy. Say you have patient A, who clearly qualifies for initiating an SGLT2 inhibitor; their A1C [glycated hemoglobin] is uncontrolled. And the clinician chooses not to [prescribe the drug]. The question is to go back to the provider and ask, “Why didn’t you do it?” That kind of information would be very helpful. Sometimes it’s lack of knowledge; sometimes it’s the hurdle.

In terms of the knowledge, the other tricky part is, who manages the diabetes? Diabetes and heart failure can both be managed by a specialist; you can have an endocrinologist managing diabetes, a cardiologist or heart specialist managing the heart failure. But in the real world, about 80% of heart failure patients are managed by their primary care doctor. For diabetes, I would assume it would be a relatively high number as well. If you’re a primary care doctor who has 15 minutes to deal with all the problems that a patient has, in addition to diabetes and heart failure, it becomes challenging to not only have the knowledge gap reduced, so that they understand: This is a drug that can be used to treat diabetes, and here’s a novel drug to treat heart failure. But they have to understand when you would use an SGLT2 inhibitor, versus a DPP-4 inhibitor, versus a GLP-1 receptor agonist, versus using insulin initially. So, these algorithms can be complex, and for heart failure, it’s even more complex.

I think the future of diabetes and heart failure management rests with electronic health records [EHRs] with logic built in—to help trigger the primary care doctor to identify patients who might benefit from some of these more novel therapies. Once a new guideline comes out, you build that into the EHR decision-making process.

EBDM™: Are we doing enough to prevent heart failure in patients with diabetes? Do we need to do more?

LEWIS: Given that diabetes is the number 2 risk factor for heart failure, we have to. Especially in patients who have what I call the trifecta—hyper tension, diabetes, and preexisting atherosclerotic cardiovascular disease—those are very high-risk populations. Lipid lowering is important, as well, in these patients, but we need some type of precision medicine approach to managing the prevention of heart failure. If you look at the natural history of patients after they develop heart failure, you’re looking at a median survival of 5 years; at best, the median survival is 8 years, if we include the asymptomatic patients.

We should absolutely come up with strategies to prevent heart failure—and that’s what excites me about the SGLT2 inhibitors. I’m waiting to see the additional trials come out to add to our understanding, but the fact that we have 2 trials that have reduced not only mortality but also reduced heart failure is very important. 

REFERENCES

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2. FDA guidance for industry. Diabetes mellitus: Developing drugs and therapeutic biologicals for treatment and prevention. US Food and Drug Administration. fda.gov/downloads/Drugs/.../Guidances/ucm071624.pdf. February 2008, Draft. Accessed October 15, 2017.

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6. Neal B, Perkovic V, Mahaffey KW, et al, for the CANVAS Program Collaorative Group. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017; 377(7):644-657. doi: 10.1056/NEJMoa1611925.

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8. EMPagliflozin outcomE tRial in Patients With chrOnic HeaRt Failure With Reduced Ejection Fraction) EMPEROR-Reduced. www.clinicaltrials.gov/ct2/show/NCT03057977. Updated October 4, 2017. Accessed October 15, 2017.

9. EMPagliflozin outcomE tRial in Patients With chrOnic HeaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved). www.clinicaltrials.gov/ct2/show/NCT03057951. Updated October 4, 2017. Accessed October 15, 2017.

10. Caffrey M. Can SGLT2 inhibitors prevent heart failure in a broad population? The American Journal of Managed Care® website. www.ajmc.com/conferences/acc-2017/can-sglt2-inhibitors-prevent-heart-failure-in-a-broad-population-results-from-a-real-world-study. Published March 19, 2017. Accessed October 15, 2017.

11. Kosiborod M, Cavender MA, Fu AZ, et al; CVD-REAL Investigators and Study Group. Lower risk of heart failure and death in patients initiated on sodium-glucose cotransporter-2 inhibitors versus other glucose-lowering drugs: the CVD-REAL Study. Circulation. 2017;136(3):249-259. doi: 10.1161/CIRCULATIONAHA.117.029190.
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