Some tremendously encouraging results from the study that is the most inclusive to date including those with CKD from a myriad of causes, minor to severely diminished eGFR levels and with or without diabetes. Some specifics:
EMPA-KIDNEY is the largest and most inclusive SGLT2 inhibitor trial in chronic kidney disease to date
The trial’s Independent Data Monitoring Committee recommended that the trial be stopped early due to evidence that the trial treatment is more effective than the placebo
Detailed results will be presented later this year.
HI I participated in the World Kidney Day presentation for BI and we talked about this. They felt it was so unfair that there was such a success in the members of the trial who were on the drug, as to the ones on placebo that it was unfair. I think this is a responsible action on their behalf. SGLT2 inhibitor definitely work. My husband is on one and is doing fabulously.
Exciting, thank you for posting Blackknight. I have AKI/CKD but my doctor said he was waiting for some research to come out on these drugs if they were good for non diabetics. I wonder when the doctors will be prescribing them for people without diabetes….?
The better question is whether or not insurance will pick up the cost since the FDA hasn't officially approved these drugs for folks without diabetes. Iffy.
On April 30, 2021 the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults with chronic kidney disease who are at risk of disease progression.
In late February 2022, the FDA signed off on Eli Lilly’s Jardiance (empagliflozin) label expansion to curb the risk of cardiovascular death and hospitalization in adults with heart failure.
Both of theses are Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a class of oral (taken by mouth) prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. However, they underperformed as diabetic specific drugs over the last 10-12 years. Yet further clinical trial data showed significant improvement in kidney function in people with diabetes who already had diabetic nephropathy. AZN used the data of the last 15 years to get Farxiga approved as the first CKD specific drug to actually treat CKD ever! All of the SGLT2 inhibitors are effective in patients with and without T2D for slowing CKD progression and reducing the risk of all-cause mortality. On the basis of these data, individualized treatment with SGLT2 inhibitors represents an unprecedented therapeutic option and an opportunity to slow the progression of CKD and the development of associated cardiovascular complications in patients with CKD, whether or not they also have T2D. However, the data for Jardiance is the most specifically tested on more than 6000 patients with stage 1-4 CKD caused by a myriad of issues and affected progression of CKD, reduced all cause mortality, protected the cardiovascular system from both fatal and non-fatal MI, stroke and TIA.
Jardiance received Fast Track, Breakthrough Therapy and Priority Review designationsfrom the FDA as Farxiga did prior to approval. Also, If approved in CKD, Jardiance would have to jockey for space alongside AstraZeneca's SGLT2 rival Farxiga, which won an approval last April to treat chronic kidney disease even in patients without diabetes. It would also have to contend—at least in part—with Johnson & Johnson’s own SGLT2 challenger, Invokana, which boasts an approval in diabetic kidney disease but not in kidney disease patients without diabetes.
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New drug to slow CKD.
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