The cardiologist discusses the lagging nature of US health care authorization and recommendation for already proven agents in cardiovascular risk reduction.
An overarching theme of The Metabolic Institute of America’s (TMIOA) 2021 Heart in Diabetes sessions in New York, NY this weekend pertained to the advancing role of SGLT2 inhibitors and GLP-1 receptor agonists in comprehensively treating metabolic, cardiovascular, and renal outcomes in patients with type 2 diabetes and comorbid disease.
This role, Matthew Budoff, MD, explained, is one that is being stalled by regulatory processes. In the second segment of an interview with HCPLive at the meeting, Budoff, Professor of Medicine at David Geffen School of Medicine at UCLA, explained why real-world application of proven cardiometabolic drug classes is lagging behind what’s been proven in clinical trials.
As Budoff explained, the US operates on a “general rule” that findings from 2 randomized trials may constitute a class I indication for a drug class. For example, he said, the DAPA-HF and EMPEROR trials supported the use of SGLT2 inhibitors for the reduced risk of heart failure in patients with and without diabetes.
That said, Budoff cited the CANVAS and EMPA-REG trials as supporting the drug class’ benefit in reducing composite cardiovascular death in patients with diabetes and atherosclerotic cardiovascular disease. Another 3 randomized clinical trials support GLP-1 receptor agonists for the reduction of composite coronary events, strokes, and all-cause death, he said.
Yet, authority recommendations and real-world utility of these drugs are not available.
“I think as we get cumulative evidence, with or without FDA guidance, I think we need to begin accepting that this is very, very solid,” Budoff said.
Budoff also discussed potential catalysts toward the application of these drug classes for greater cardiovascular benefits in patients with diabetes, and the possibly disparate perspectives that still exist between diabetologists and cardiologists who may be treating many of the same patients.
“As a person who has not been embedded in the diabetes world as strongly as my endocrinology colleagues, I think it just behooves us to stop using DDP4 inhibitors…we really have to think about using drugs that have cardiovascular benefits,” he said.