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Cardiovascular Results for Dapagliflozin Point to SGLT2 Use to Prevent Heart Failure

Mary Caffrey
Results presented at the American Heart Association in Chicago provided the strongest evidence to date on what heart failure specialists have discussed for several years now: the possibility that SGLT2 inhibitors might be used to prevent heart failure in patients with type 2 diabetes.
Results from the 17,000-patient cardiovascular outcomes trial for dapagliflozin, the sodium glucose co-transporter 2 (SGLT2) inhibitor sold as Farxiga (AstraZeneca), presented today at the American Heart Association (AHA) annual meeting in Chicago show the type 2 diabetes (T2D) drug safely controls blood glucose, significantly reduces hospitalization for heart failure, and may slow the loss of kidney function. The drug did not produce the same mortality benefits seen with competitors in the class.

The big news, however, is what heart failure specialists have wondered about for some time—dapagliflozin, and perhaps the entire SGLT2 class, might someday be used to prevent heart failure among a much larger group of T2D patients who are at risk but have not become seriously ill. In the United States, 30 million people have diabetes; all but 1.25 million have T2D. About 5.7 million people have heart failure, and diabetes is a leading cause. About half of those with heart failure die within 5 years of diagnosis.

“The SGLT2 inhibitor benefits for heart failure and renal dysfunction were quite consistent for all populations of patients, with or without pre-existing atherosclerotic cardiovascular disease (ASCVD),” and with and without pre-existing heart failure or kidney disease, said lead study author Stephen D. Wiviott, MD, FACC, of Brigham and Women’s Hospital, in an interview with The American Journal of Managed Care® (AJMC®). The study published simultaneously in the New England Journal of Medicine.1

Previous cardiovascular outcomes trials for the SGLT2 inhibitors empagliflozin (Jardiance, Eli Lilly/Boehringer Ingelheim) and canagliflozin (Invokana, Janssen) prompted the American Diabetes Association and the European Society of Cardiology to revise guidelines for patients with known cardiovascular disease. DECLARE-TIMI 58 presented in Chicago at the American Heart Association annual meeting, was designed differently from those trials and included more than 10,000 patients who had risk factors for ASCVD but had not developed the disease.

The results offer the strongest evidence to date that treating healthier T2D patients with SGLT2 inhibitors can prevent heart failure among those at risk for this condition, a finding that could have enormous impact on managed care. The Framingham Heart Study has found that women with diabetes are 5 times more likely to develop heart failure, and men 2.4 times more likely to develop it. Patients with heart failure are among the sickest in the health system, with total costs of $30 billion a year, according to the CDC.

“These new data suggest that in patients without established atherosclerotic cardiovascular disease, SGLT2 inhibition can prevent serious clinical events, particularly hospitalization for heart failure, and possibly reduce the likelihood of progression of renal disease,” the authors wrote in their findings.

A meta-analysis of the 3 major cardiovascular outcomes trials involving SGLT2 inhibitors, appearing in The Lancet appearing less than an hour after presentation of the DECLARE-TIMI 58 results, found that drugs in this class appear to be producing modest results in reducing heart attacks and strokes, but "robust" outcomes in reducing hospitalization for heart failure and progression of renal disease.2

Under a 2008 FDA guidance, makers of all T2D therapies were required to conduct large cardiovascular outcomes trials to ensure that the drugs did not cause heart attacks, strokes, or early cardiovascular death. The diabetes community was stunned in September 2015 when results from EMPA-REG OUTCOME showed that empagliflozin was not only safe, but also produced a 38% reduction in cardiovascular deaths and a 32% reduction in deaths from any cause, in addition to a 35% reduction in hospitalization for heart failure.

Canagliflozin followed in June 2017 with results from CANVAS, which found a 14% reduction in a composite outcome of reduction in death from cardiovascular causes, myocardial infarction, and stroke, but an increased risk of lower extremity amputation. The CANVAS results also showed a delay in loss of renal function and a reduction in hospitalization for heart failure; while the reduction was greater for those with established heart failure (39% vs 13%), CANVAS also hinted at a protective benefit that should be confirmed in other trials.

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