MedicalResearch.com Interview with:
Naeem Khan MD
Vice President at AstraZeneca
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: A pre-specified exploratory analysis of renal data from the DECLARE-TIMI 58 trial, the largest SGLT-2 inhibitor (SGLT-2i) cardiovascular outcomes trial (CVOT) conducted to date, showed that FARXIGA (dapagliflozin) reduced the composite of kidney function decline, end-stage renal disease (ESRD) or renal death by 47% in patients with type 2 diabetes (T2D).
Additionally, FARXIGA reduced the relative risk of a cardio-renal composite of kidney function decline, ESRD, or renal or cardiovascular (CV) death by 24% compared to placebo.
The analysis evaluated 17,160 patients with type 2 diabetes and predominantly preserved renal function, irrespective of underlying atherosclerotic CV disease (ASCVD).
MedicalResearch.com: What should readers take away from your report?
Response: The landmark DECLARE-TIMI 58 trial offers a rich body of scientific evidence evaluating renal and CV outcomes in patients with type 2 diabetes, making it highly relevant to the real-world clinical setting. The analyses provide important insights into addressing the interconnectivity of diabetes and kidney disease, as chronic kidney disease (CKD) is an early and frequent complication of type 2 diabetes, is often overlooked, and can be fatal.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: Research, like DECLARE-TIMI 58, that evaluates innovative approaches to address cardio-renal risk in T2D patients is more important than ever before. People with diabetes have a six-to-twelve times higher risk of developing ESRD and are approximately twice as likely to develop CKD than those without. It is important to have data that helps understand how we may better address renal and CV complications for these patients.
DECLARE is part of the extensive DapaCare clinical program for FARXIGA, and aims to generate data across a spectrum of people with CV risk factors, established CV disease and varying stages of renal disease, both with and without T2D. The next wave of outcomes trials for dapagliflozin including DAPA HF and DAPA CKD are designed to understand the effect of dapagliflozin on disease area studied (in this case HF or CKD respectively) regardless of whether the patient has been diagnosed with diabetes.
The DAPA CKD trial is designed to evaluate the effect of dapagliflozin on renal outcomes and cardiovascular mortality in patients with chronic kidney disease and includes both patients who have diabetes and those who do not It is a randomized, multicenter, event-driven, double-blind, placebo-controlled study involving 4,000 patients with chronic kidney disease. The primary outcome is defined as the composite of time to first occurrence of ≥50% sustained decline in eGFR, reaching end stage renal disease (ESRD) or CV death or renal death. ESRD is defined as sustained eGFR <15 mL/min/1.73m2, chronic dialysis treatment or receiving a renal transplant.
DAPA HF is expected to read out in 2019 and DAPA CKD is expected to read out in 2020.
MedicalResearch.com: Is there anything else you would like to add?
Response: Both diabetic kidney disease and HF are often under-recognized, but are in fact two of the most early, common and serious complications of type 2 diabetes. Additionally, diabetes is the leading cause of kidney failure, accounting for 44% of new cases. At AstraZeneca, we remain committed to jointly addressing patients’ cardio-renal-metabolic risks through our industry-leading portfolio and robust clinical programs.
Renal Outcomes from the DECLARE-TIMI 58 Trial: Quantifying the Health-Care Implications
PHILIP MCEWAN, BERNT KARTMAN, HAYLEY BENNETT, CHRISTOPHER EDMONDS and INGRID ANNA GAUSE-NILSSON
Diabetes 2019 Jun; 68 (Supplement 1): 15-OR. https://doi.org/10.2337/db19-15-OR
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