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Forxiga study shows reduced progression of kidney disease in patients with type-2 diabetes

Chronic Renal Disease (CKD) is one of the most common early complications experienced by people living with type-2 diabetes (T2D), and often overlooked as its often asymptomatic. If left undiagnosed and unmanaged, it can lead to fatal outcomes. Multiple studies have shown that 40% of all people with T2D develop CKD, a debilitating condition that worsens over time and currently has no cure or treatment to halt or reverse the deterioration of the kidney.

AstraZeneca’s treatment for type 2 diabetes dapagliflozin (Forxiga), available to patients in India showed a 47% reduction in the composite kidney function decline, end-stage renal disease or renal death in a pre-specified analysis from the DECLARE-TIMI 58 clinical study.

Forxiga is an inhibitor of SGLT2 indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. Forxiga is not approved to reduce the risk of renal or CV death, or to slow the progression of kidney disease.

A pre-specified exploratory analysis of renal data from the Phase III DECLARE-TIMI 58 trial, the broadest cardiovascular outcomes trial of a sodium-glucose co-transporter 2 (SGLT2) inhibitor, showed that Forxiga (dapagliflozin) reduced the progression of kidney disease or renal death in patients with type-2 diabetes (T2D).

These data, presented on June 10 at the American Diabetes Association’s (ADA) 79th Scientific Sessions, San Francisco, USA, and simultaneously published in The Lancet Diabetes & Endocrinology, showed a 47% reduction with Forxiga in the relative risk of the composite renal-specific outcome of kidney function decline (sustained ≥40% decrease in estimated glomerular filtration rate [eGFR] to <60 mL/min/1.73m2), end-stage renal disease (ESRD), or renal death (excluding cardiovascular death) compared to placebo (1.5% vs. 2.8%; HR 0.53 [95% CI 0.43-0.66]).

Additionally, Forxiga 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 (4.3% vs. 5.6%; HR 0.76 [95% CI 0.67-0.87]).

This analysis evaluated 17,160 patients with T2D and predominantly preserved renal function, irrespective of underlying atherosclerotic CV disease (ASCVD). People with diabetes have a six-to-twelve times higher risk of developing ESRD and are approximately twice as likely to develop chronic kidney disease (CKD) than those without.

Elisabeth Bjork, Senior Vice President, Head of Late-stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, said: “Heart failure and renal diseases are two of the most common and early complications experienced by people living with type-2 diabetes, and are too often overlooked. They contribute to a growing economic burden on the global healthcare system and can lead to fatal outcomes for patients. These data continue to offer clinically relevant evidence of the early cardio-renal effects of Forxiga.”

While ESRD was a rare event in the trial, the incidence was lower in the Forxiga arm compared to placebo (0.1% vs. 0.2%; HR 0.31 [95% CI 0.13-0.79]). The renal-specific outcome was consistent across subgroups regardless of eGFR or urinary albumin-to-creatinine ratio (UACR) category, whether they had established ASCVD or multiple CV risk factors.

These data were presented alongside other clinically important renal outcomes data from the DECLARE-TIMI 58 trial, including positive results from another sub-analysis that evaluated UACR, a key marker of kidney health. Forxiga improved renal function as measured by changes in UACR (improved from micro- to normo-albuminuria [HR 1.35, 95% CI {1.24, 1.47}], improved from macro- to micro- or normo-albuminuria [HR 1.55, 95% CI {1.34, 1.8}], and decreased deterioration from normo- to micro- or macro-albuminuria [HR 0.84, 95% CI {0.79, 0.89}]).

DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58 is an AstraZeneca-sponsored, randomised, double-blinded, placebo-controlled, multicentre trial designed to evaluate the effect of Forxiga compared with placebo on CV outcomes in adults with T2D at risk of CV events, including patients with multiple CV risk factors or established CV disease. DECLARE included more than 17,000 patients across 882 sites in 33 countries and was independently run in collaboration with academic investigators from the TIMI study group (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

Forxiga (dapagliflozin) is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2) indicated as both monotherapy and as part of combination therapy to improve glycaemic control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise in adults with T2D. Forxiga has a robust clinical trial programme of more than 35 completed and ongoing Phase IIb/III trials in over 35,000 patients, as well as more than 1.8 million patient-years’ experience.

AstraZeneca, a global, science-led biopharmaceutical company, focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology; Cardiovascular, Renal & Metabolism; and Respiratory. The company operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

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