More good news in research: Clinical trials show dramatic results for Farxiga® in treating CKD

The article below from the American Kidney Fund was received today and I thought it was a good idea to share the information with everyone here. It's still a way off but the news is encouraging.

For individuals living with chronic kidney disease (CKD), advances in treatment offer significant hope for improved outcomes in slowing the disease’s progression and treating its comorbidities, especially cardiovascular disease.

In the news, today are the results from the ground-breaking Phase III DAPA-CKD clinical trial showing that AstraZeneca’s Farxiga® (dapagliflozin) dramatically reduces the risk for both progressions of kidney disease and cardiovascular death in patients with and without diabetes.

Farxiga was approved by the FDA in May 2020 for patients with heart failure. AstraZeneca will ask the FDA to approve its use in treating CKD.

In a press release, the company’s head of research and development said, “With today’s results, Farxiga becomes the first SGLT2 inhibitor proven to significantly prolong the survival of patients with chronic kidney disease with and without type-2 diabetes and we look forward to sharing these data with regulatory authorities around the world. Farxiga is also the first medicine in its class to demonstrate benefit in treating both heart failure and chronic kidney disease in patients with and without type-2 diabetes, and reduce the risk of hospitalization for heart failure and nephropathy in type-2 diabetes.”

SGLT2 inhibitors help type-2 diabetics by prompting the kidneys to eliminate excess blood glucose through the urine. Farxiga was shown in the study to cut the risk of dying from any cause for people suffering from chronic kidney disease by 31% when compared to a group on placebo.

Posted: August 31, 2020, | Author: AKF staff

[orangecity41 NKF Ambassador]

I was just reading this on Facebook for American Kidney Fund. Thanks for sharing

[WinJ3]

Thanks for sharing!!

[HealthBuddyMelissa]

I read this too in my email. It does sound promising if you have Diabetes. I looked up the side effects, though, and I was discouraged.

[itzmich in reply to HealthBuddyMelissa]

One criteria is protein in the urine which I have. I don't have diabetes and at stage 3. Been taking Farxiga for 3 months no side effects.

[RoxanneKidney in reply to itzmich]

what is your dosage?

[itzmich in reply to RoxanneKidney]

10mg

[RoxanneKidney in reply to itzmich]

are you also on another bp med?

[itzmich in reply to RoxanneKidney]

Yes 2 different kinds.

[drmind]

Thanks for sharing this. Its always positive to get good news

[My_Kidneys]

I received the same e-mail yesterday. I started researching this product, a diabetic drug, Ertugliflozin (Farxiga® ) made by AstraZeneca. In conclusion, the researchers found:

"In patients with T2DM and stage 3 CKD who were inadequately controlled on their existing antihyperglycemic therapy, the addition of ertugliflozin showed evidence of pharmacologic activity in glycemic control and body weight and BP reduction, although the comparison with the placebo group was not statistically significant. Ertugliflozin was generally well tolerated and the safety profile was largely consistent with that observed in phase 3 clinical trials of patients with T2DM and normal renal function, except for a higher incidence of hypovolemia in the present study."

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

[Darlenia]

Reporting from the NIH (Nat'l Institute of Health), a gov't institution, is generally more reliable than those from the drug companies and professional trade/lobby organizations. It appears there are no magic bullets out there, sadly. Apparently, dietary and lifestyle changes are still one's best approach for most of us.

[Hidden in reply to Darlenia]

I agree about diet and exercise being the best way, at this time, to slow the progression of CKD. However, unless we can be sure that government agencies aren't being steered in a certain direction by administration meddling, caution must be taken. The fact that the American Kidney Fund sought to post this in a newsletter I decided it was worth sharing. If that drug can get through the remaining phases it would still be up to the Care Team to determine its efficacy for each diabetic nephrology patient. Hope for the best, but stick with your kidney-friendly meal plan and exercise regimen.

[My_Kidneys in reply to Darlenia]

I would generally agree. Be very mindful and cautious to not let the politics of government, drug companies, professional trade/lobby organizations and etc. taint or influence you. What I believe, a double blind study published in a peer reviewed journal is the most reliable.

[Darlenia]

True. I worry profits, sales, and kickbacks will continue to play interference in the many aspects of our health. It does seem that many entities are either funded by corporations or influenced by outside business/political interests. Unfortunately, we've seen so many medications come and go, particularly for diabetics, that we've gotten a bit jaded. Like you, we'll continue on with our diet and lifestyle.

[Hidden in reply to Darlenia]

I'm strict with my plan and do enjoy my lifestyle but it is something to hope for.

[My_Kidneys in reply to Darlenia]

I agree!

[theladymay]

I just read this same basic news in a medical bulletin I receive the other day. As a T2 diabetic (due to high dose steroid treatment years back for what turned out to be a refractory ulcerative colitis that eventually required a total procto-colectomy) who had acute kidney failure in 2012 that once resolved left me in CKD 3A, my glycemic control had been problematic as the AKI made metformin and glipizide/other sulfonylureas unusable. Through exercise and diet alone my A1cs were 8 & heading north *quickly* with my best efforts; adding victoza helped a little but not enough to make us stop seeing insulin in my near future. Of course if insulin becomes necessary I'll be there, but it has drawbacks with weight etc and it would be great if I could keep to <7% (or ideally @ 6%) without it. My doctor added q-tern which is a combination of 5mg each Farxiga (dapagliflozin) & saxagliptin, neither of which produce hypos or are likely to damage my kidneys I was thrilled that my A1c moved to a what looks to be a stable 7.2 - and my egfr jumped up from @62-65 to 75 -78 which I definitely wasn't expecting! So finally, a T2 med that not only won't produce hypos, or push my kidneys - it's actually produced undeniable positive results for both my DM and the CKD! No GI side effects either which with my IBD is a win.

For me, great news. Im going to ask my Dr next visit if we can try QternXL with 10mg dapagliflozin/5mg Saxagliptin.

Could I see 6-ish again - without hypos or weight gain? We'll see! ☺️

[RoxanneKidney in reply to theladymay]

I want to try the dapagliflozin. Dr. recommended 10 mg. I am on Lisinopril 2.5 mg and already my bp is REALLY low. I want the added benefit, but I don't need a lower bp?? Are you on an ACE or ARB in addition to the Farxiga?

[theladymay in reply to RoxanneKidney]

No, my blood pressure is low enough that I don't need meds for it.

[Hidden]

That's good to hear. I'm only guessing since I don't know the staff at the AKF who wrote the story I posted but patients with a similar story to yours may be the GOOD NEWS they referred to. That is still in trials so you may want to hold off on it until Astra-Zeneca releases their complete findings after the trials are over and the results are determined by reliable medical experts without any other agenda.

[MPStilwell]

Anybody seeing any results on this drug?

[Hidden in reply to MPStilwell]

Farxiga has been released but since there is no generic a months supply is approx. $500.00+.If you want detailed information on Farxiga go to drugs.com. Other than that I have seen nothing on the end results of the clinical trials.

[MPStilwell in reply to Hidden]

Have you looked? The results are extremely easy to find and encouraging... I was able to get on the help plan and now receive it for free. Pretty easy process and seeing great results. $500 a month is a lot but if I had to pay it, I would. If it works like the results show and like it has been for me, it is 100% worth every penny. But again, its fairly easy to get for free if your doc helps.

[Hidden in reply to MPStilwell]

I made that post 30 days ago and then the information was not available. I know it is now online. Thanks.As I mentioned earlier to someone, if you don't have T2D I would strongly recommend you avoid this medications as it could put you in the path of becoming hypoglycemic. Just a caution, so if you have T2D and if you can afford it then go for it.

[RoxanneKidney in reply to MPStilwell]

there is a lot on you tube about the drug

[itzmich in reply to Hidden]

I'm on Medicare and a suppliment and my prescription is about $33.00 monthly. Also can get discounts or free directly through Farxiga.

[RoxanneKidney in reply to itzmich]

The more I read about this drug, the more I want to try it. We have nothing else.

[itzmich in reply to RoxanneKidney]

I agree..I.still stay on a kidney healthy diet, exercise daily and hope.

[RoxanneKidney]

Amen to that.