Jardiance Approved for CKD

[orangecity41]

Article from Drugs.com

FDA Clears Jardiance for Use in Chronic Kidney Disease (CKD)

In September, the FDA cleared Jardiance (empagliflozin), from Boehringer Ingelheim and Eli Lilly, to reduce the risk of further worsening of kidney disease, end-stage kidney disease (ESKD), death due to cardiovascular disease, and hospitalization in adults with chronic kidney disease (CKD).

This is the fourth approved use for Jardiance, a sodium glucose co-transporter-2 (SGLT2) inhibitor also used for cardiovascular risk reduction, heart failure, and to improve glycemic (blood sugar) control in type 2 diabetes.

Approval was supported by the Phase 3 EMPA-KIDNEY study with over 6,600 patients. Jardiance, in addition to standard care, demonstrated a 28% relative risk reduction (HR=0.72; 95% CI 0.64 to 0.82; P<0.0001) compared with placebo, for the composite primary endpoint of kidney disease progression or cardiovascular death. A 14% relative risk reduction in first and recurrent hospitalization, a key secondary endpoint, was also seen vs. placebo (HR=0.86; 95% CI 0.78 to 0.95; p=0.0025).

The recommended dose for this use is 10 mg orally once daily in the morning, taken with or without

[newbie56]

Side effects???

[Blackknight1989]

Almost none compared to the control group in SEVERAL studies syarting with the EMPA-Kidney study. Link: healio.com/news/nephrology/...

Link to EMPA-kidney study:

nejm.org/doi/full/10.1056/N...

[orangecity41 NKF Ambassador in reply to Blackknight1989]

Thanks for sharing links to the study.

[Blackknight1989 in reply to orangecity41]

My pleasure thank you for the prompt reporting…it’s (to me) big news!

[orangecity41 NKF Ambassador in reply to Blackknight1989]

You are welcome.

[citruskayaker]

Nice post. I can't help but wonder what stage of CKD one should consider this drug and the costs associated with it.

[orangecity41 NKF Ambassador in reply to citruskayaker]

Good question. Imagine your Doctor would recommend, especially if are pre -diabetic or diabetic?

[Blackknight1989 in reply to citruskayaker]

Here is some info that may help. If you don’t want to read the entire study I’ll post the conclusion:

Empagliflozin is the latest SGLT2i drug to show proven benefits in both hyperglycemia, CV disease, heart failure, and now CKD progression. The new EMPA-KIDNEY data proves that it provides benefits in patients with and without diabetes and can be used in those with eGFR down to 20 mL/min/1.73m2. The medication is further solidified as an important tool to combat CKD progression and avoidance and delay of CV risk factors. Adverse events appear to be minimal and are in line with previous trials and other medications in the SGLT2i class. We encourage clinicians to digest this data and consider adding SGLT2i to RAASi in the appropriate patients. Further guideline changes are expected and we feel encouraged to have advanced therapies like empagliflozin to combat chronic kidney disease.

Here is the link and I encourage you to read and save the study as it is my believe most doctors are unaware of the benefits to SGLT2 inhibitors in non-T2D patients with CKD:

ncbi.nlm.nih.gov/pmc/articl...

As always have the discussion with a trusted physician and if you don’t have a trusted physician find one who is willing to listen and sees you as an active participant in your own health outcomes! My best to you!

[orangecity41 NKF Ambassador in reply to Blackknight1989]

Thanks so much for sharing. I have hyperglycemia and stage 3 CKD. I will discuss with my PD tomorrow when have appointment. My eye Doctor thinks I need intervention .

[Blackknight1989 in reply to orangecity41]

My pleasure and good luck with your appointment. If you are willing please update with your results following you appointment. I have an interest as the two nephrologist I’ve seen here in BFE Arkansas gave me this reply,”you are not diabetic so why would you need Jardiance?” Then in “my chart” following appointment the had diagnosed me with “well controlled diabetes”. I emailed the nurse with the studies posted here and the reply was “the doctor thinks you need to find another physician who will better suit your needs as we don’t want patients who try to correct our advice or diagnosis.” Unwilling to learn or help so I am interested in your experience if you don’t mind sharing. My best to you on your appointment abd CKD journey!

[orangecity41 NKF Ambassador in reply to Blackknight1989]

I will keep you posted. I guess many factors to look at.

[citruskayaker in reply to Blackknight1989]

Very helpful. It is difficult for active nephrologists to keep up with this and all CKD patients should ask their physicians to look at this. None of us want to end up on dialysis... which statistically is a death sentence over a period of years for most patients.

[Blackknight1989]

Thank you and best of luck!

[Turtlepad513]

Just a note of experience. I had a gfr of 20, and in 2 months it tanked my gfr to 14. Now back up to 16, but been off it for 3 months.

[orangecity41 NKF Ambassador in reply to Turtlepad513]

It may not be for everyone.

[Blackknight1989 in reply to Turtlepad513]

The initial drop in eGFR is part of the reaction to this particular class of drugs. However several studies have been done to show that this initial drop is neither harmful or concerning. Certainly with an eGFR of 20 (as mine is) a drop to stage 5 numbers is scary, it is according to thes studies neither permanent nor should it be a factor for discontinuing the treatment as eGFR wil risie again after an in total 3-8 week drop. It is situations like this where both patients and physicians education is essential. Please note I’m not downplaying your issues just putting the info out there that it is a common response to these meds. As always it should be a discussion with you trusted physician to determine what is best for you. My best of luck to you in your CKD journey!