Dapagliflozin new indication approved! Can be used for the treatment of chronic kidney disease

According to the National Medical Products Administration (NMPA) and related pharmaceutical companies, the dapagliflozin chronic kidney disease indication has been approved in China to reduce the risk
of persistently decreasing estimated glomerular filtration rate (eGFR), end-stage renal disease, cardiovascular death and hospitalization due to heart failure in adults with chronic kidney disease at risk of progression.
The approval of the indication is based on the positive results of the DAPA-CKD Phase III trial and marks the approval of China's first sodium-glucose cotransporter 2 inhibitor (SGLT-2i) for chronic kidney disease
in adults and non-type 2 diabetic patients.

The number of patients with chronic kidney disease in China is as high as 120 million

Chronic kidney disease (CKD) is a severe condition in which patients experience a progressive decline in kidney function (marked by decreased eGFR or kidney damage or both, and persists for more than three months
).
The most common causes of chronic kidney disease are diabetes, hypertension, and glomerulonephritis
.
Patients with chronic kidney disease are at significantly increased
risk of complications and cardiovascular events such as heart failure and premature death.
Once a patient enters the most severe stage of chronic kidney disease, end-stage renal disease (ESKD), his kidneys are severely damaged and his kidney function progressively deteriorates, and he can only be kept alive
through dialysis or kidney transplantation.
Most people with chronic kidney disease die
from cardiovascular disease before progressing to end-stage renal disease.
There are currently up to 120 million patients with chronic kidney disease in
China.

39% reduction in relative risk for primary cardiorenal endpoints and 31% relative risk of all-cause mortality

The DAPA-CKD Phase III trial showed that dapagliflozin reduced the relative risk of the primary endpoint of deterioration of renal function, end-stage renal disease, cardiovascular disease, or death from cardiovascular disease by 39% compared with placebo in patients with elevated stage 2 to 4 urine albumin (absolute risk reduction [ARR] = 5.
3%, p<0.
0001) compared with placebo.

。 Compared with placebo, dapagliflozin significantly reduced the relative risk of all-cause mortality by 31% in patients with chronic kidney disease (ARR=2.
1%, p=0.
0035).

The safety and tolerability of dapagliflozin are consistent
with the known safety profile of the drug.

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