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On October 23rd AstraZeneca published the results of a new subgroup analysis of DAPA-CKD, a breakthrough Phase 3 clinical study, showing that Farxiga (dapagliflozin, Dagliflozin, Daglile net) reduced the risk of kidney failure or cardiovascular (CV) and kidney disease death in patients with chronic kidney disease (CKD) regardless of the underlying cause.
in this subgroup analysis, the proportion of patients with CKD treated with Farxiga reduced the relative risk (RRR), mainly caused by diabetic nephropathy, by 37% (absolute risk reduction by 5.8%) compared to placebo; ARR was 2.2%); NGR RRR was 57% (ARR was 7.5%); and CKD patients with other unknown causes were 42% (ARR s 5.0%) (RRR interaction p value 0.53).
, Farxiga therapy showed a decrease in all-cause mortality (interaction p-value 0.55) (secondary endpoint) compared to placebo, regardless of the patient's underlying CKD cause.
addition, Farxiga's safety and tolerance are consistent with the safety previously observed by the drug.
DAPA-CKD is an international, multicenter, randomized, double-blind Phase 3 trial that recruited 4,304 CKD patients to assess the efficacy of 10 mg of Farxiga in patients with or without type 2 diabetes (T2D) and CKD patients with elevated urinary albumin excretion compared to placebos.
study, patients took Farxiga once a day in addition to standard care.
In August 2020, detailed results published in the New England Journal of Medicine showed that Farxiga reduced renal function in patients (defined as a 50% continuous decline in eGFR, a compound result of ESKD onset and death from CV disease or kidney disease≥) or in kidney and CV mortality (the main compound endpoint) by 39% (p.lt;0001) compared to placebo.
positive results were consistent in patients with and without T2D.
Farxiga also reached all secondary endpoints, reducing the proportion including the first time a renal disease complex (continuous ≥50% eGFR decline, ESKD and kidney death), CV death or hospitalization for heart failure (hHF), and all-cause death by 31% (ARR-2.1%, p-0.0035). Professor Hiddo L. Heerspink, co-chair of the executive committee of the
DAPA-CKD trial at the University medical center in Groningen, Netherlands, said: "The results of this release demonstrate the potential of Farxiga to change standards of care for patients with a wide range of chronic kidney diseases and do not emphasize the underlying causes of patients.
will open up huge possibilities for millions of people with chronic kidney disease around the world.
" Mene Pangalos, Executive Vice President, Biopharmaceutical Research and Development, AstraZenecon, said, "In trials of renal disease outcomes in patients with or without type 2 diabetes, DAPA-CKD demonstrated Farxiga as the first SGLT2 inhibitor to significantly extend the survival potential of patients.
"CKD is a serious, remnantive disease determined by a decrease in renal function (at least three months of reduced cyspheric leaching rate (eGFR) or renal damage markers, or both).
estimated that some 700 million people worldwide are affected, many of whom remain undiagnosed.
the United States, one-third of adults, or about 80 million people, are at risk of CKD.
CKD are diabetes (38%), hypertension (26%) and nephroten nephritis (inflammation of the kidneys, 16%).
its most severe form, end-stage kidney disease (ESKD), kidney damage and deterioration of kidney function have developed to the stage where dialysis or kidney transplantation is required.
most CKD patients die of cardiovascular disease before they reach ESKD.
earlier in October, Farxiga was awarded a breakthrough therapy in the United States for treating patients with or without T2D CKD and was recommended by the European Commission for Medicines for the treatment of heart failure (HF).
addition, in May 2020, Farxiga was approved in the United States to reduce the risk of CV death and hHF in adult patients with and without T2D and decreased blood score (HFrEF) (NYHA II-IV).
Farxiga is a "first-in-class" daily oral sodium-glucose co-transport protein-2 (SGLT2) inhibitor used as a monotherapy and as part of dietary and exercise-assisted therapy to treat under-controlled T2D patients for improved blood sugar control and with additional benefits for weight loss and lowering blood pressure.
in the CV outcome trial DECLARE-TIMI 58 in adult patients with T2D, Farxiga showed a reduced risk of hHF or CV death compound outcomes in patients compared to placebo.
currently, the drug is being evaluated in deLIVER (for HF (HFpEF) and DETERMINE (for HFrEF and HFpEF) trials for HF patients, and in DAPA-MI trials for patients with acute myocardial infarction (MI) or without T2D after a heart attack.
source: Farxiga DAPA-CKD Phase III trial reducedd deterioration of the kidney function, risk of kidney deterioration and risk of death in patients with cardiovascular or renal death in patients with chronic kidney disease, irrespective of underlying causeing