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American Diabetes Association 2019

DECLARE Shows Diabetes Drug Farxiga Prevented Renal Decline, Even for Those With Good Kidney Health

Mary Caffrey
Findings reported at the 79th Scientific Session of the American Diabetes Association in San Francisco, California, show the type 2 diabetes drug dapagliflozin significantly reduced the risk of renal decline, kidney failure, and renal death.
Data from the DECLARE-TIMI 58 study, the cardiovascular outcomes trial (CVOT)  for dapagliflozin (Farxiga), show the type 2 diabetes (T2D) drug significantly reduced the risk of renal decline, kidney failure, and renal death, according to results presented Sunday.1

Findings reported at the 79th Scientific Session of the American Diabetes Association (ADA) in San Francisco, California, and published simultaneously in Lancet Diabetes & Endocrinology, say treatment with the sodium glucose co-transporter 2 (SGLT2) inhibitor made a difference even for those in good renal health when the study began, a point that study authors noted, as a dedicated renal outcomes trial for dapagliflozin is forthcoming.

“The effect of SGLT2 inhibitors on nephropathy is being examined in dedicated studies of renal outcomes, both in patients with and without type 2 diabetes,” wrote study authors led by Ofri Mosenzon, MD, of Hadassah Hebrew University in Jerusalem. “However, these trials focus on populations with nephropathy at baseline, and therefore should be considered as complementary to our findings.”

The need for better solutions to prevent renal decline in diabetes—and the apparent ability of SGLT2 inhibitors to offer options—are a major focus of this year’s ADA Scientific Sessions. People with diabetes are twice as without people without diabetes likely to develop chronic kidney disease (CKD) and at least 6 times more likely to develop end-stage renal disease (ESRD), one of the most debilitating conditions for patients and one of the costliest for the health system. The cost of dialysis per patient is estimated at $89,000 per year; patients who reach this point automatically qualify for Medicare. Estimates show that 750,000 people in the United States have ESRD, and this number has been projected to increase due to rising rate of obesity.

Like other CVOTs, DECLARE was required to demonstrate safety under a 2008 FDA guidance. Investigators expanded the trial to include hospitalization for heart failure as a second primary end point, after the 2015 EMPA-REG OUTCOME trial unexpectedly showed the SGLT2 inhibitor empagliflozin reduced cardiovascular death by 38% and hospitalization for heart failure by 35%.

Thus, DECLARE is the only trial for an SGLT2 inhibitor to report a reduction in hospitalization for heart failure and cardiovascular death as a primary end point.

DECLARE investigators previously presented findings at the American Heart Association meeting November 20182 and the American College of Cardiology Scientific Sessions in March, focusing on the drug’s ability to prevent complications from heart failure.

Taken together, the results mean “We’re almost at a turning point here in treating the diabetic patient and their comorbidities or complications,” Kiersten Combs, vice president for US Cardiovascular & Metabolic Disease for AstraZeneca, the maker of dapagliflozin, said in an interview with The American Journal of Managed Care® (AJMC®).

In the past, the conversation with health systems has been about how well a T2D therapy controlled blood glucose levels, but the growing body of evidence for cardiorenal results generates a broader conversation, said Naeem Khan MD, vice president of Medical for US Cardiovascular and Metabolic Diseases, AstraZeneca, said in the interview with AJMC®.

 “Now, the evidence has brought us to a point where we say, diabetes is a risk factor that affects other vital organs, and the organs are the heart and the kidney,” he said. The DECLARE data had already produced a primary endpoint showing the dapagliflozin reduced hospitalization for heart failure and cardiovascular death, Khan said, and now the data show benefits for the renal system.

Given the grim trajectory for patients with diabetes who develop who develop cardiovascular disease and CKD, the results “change the whole paradigm,” he said.

“What you’re seeing, which is so exciting, with the SGLT2 class, and with Farxiga specifically with DECLARE, is this body of evidence around how treating beyond the A1C [glycated hemoglobin] improve these patients’ quality of life and slow not only the diabetes [but also] the disease that the diabetes can exacerbate,” Combs said.

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