Auld Lang Syne Already?

It’s the last few days of 2019 and this year has whizzed by. My dance with pancreatic cancer has been a trip I could have done without, but the birth of my grandson more than made up for it. Now I get to see him all the time and I only have one more regiment of chemotherapy to go.

Oh, there I go again assuming everyone knows what Auld Lange Syne is. According to Classic FM at https://www.classicfm.com/discover-music/auld-lang-syne-lyrics-and-origins/:

What does ‘Auld Lang Syne’ mean?

The most accurate plain English interpretation of the Auld Lang Syne’s famous title is ‘Old long since’, or ‘For the sake of old times’.

The song itself is reflective in nature, and is basically about two friends catching up over a drink or two, their friendship having been long and occasionally distant.

The words were written by Scottish poet Robert Burns in 1788, but Burns himself revealed at the time of composing it that he had collected the words after listening to the verse of an old man on his travels, claiming that his version of ‘Auld Lang Syne’ marked the first time it had been formally written down.

However, an earlier ballad by James Watson, named ‘Old Long Syne’, dates as far back as 1711, and use of the title phrase can be found in poems from as early as the 17th century, specifically works by Robert Ayton and Allan Ramsay.”

The song is usually sung at the stroke of midnight on New Year’s Eve and is closely associated with the ending of one year and the beginning of the next. That’s tomorrow night.

Before we leave 2019, let’s take a look at what’s been happening in the kidney world this year.

The ball got rolling, so to speak, with this announcement:

“The Advancing American Kidney Health initiative, announced on July 10, 2019 by the US Department of Health and Human Services (HHS), places the kidney community in the national spotlight for the first time in decades and outlines a national strategy for kidney diseases for the first time …. In order to achieve the Advancing American Kidney Health initiative’s lofty goals and make good on the KHI’s commitment to people with kidney diseases, drug and device innovation needs to accelerate.”

You can read the entire announcement from the Clinical Journal of the American Society of Nephrology at https://cjasn.asnjournals.org/content/early/2019/12/05/CJN.11060919.

The American Kidney Fund at https://www.kidneyfund.org/advocacy-blog/future-of-dialysis-innovation.html announced prizes for innovations in dialysis. We are now in phase two.

“HHS and ASN collaborated with patients, nephrologists, researchers and others in planning the competition. Several agencies, including the National Institutes of Health, the Food and Drug Administration, and the Centers for Medicare & Medicaid Services, are involved in this effort. AKF has provided comments to the KidneyX project, urging a focus on unmet needs and improving patient quality of life.

The KidneyX: Redesign Dialysis competition will have two phases. During phase one (late-October 2018-February 2019), innovators will be asked to come up with ideas to ‘replicate normal kidney functions and improve patient quality of life.’ During phase two (April 2019-January 2020), innovators will be asked to develop prototypes to test their ideas.

The HHS press release detailing the competition can be found here.

You can also read my blog about KidneyX by using the topic dropdown on the right side of the blog.

S.1676/H.R 3912 was passed this year, too. According to Renal Support Network at https://www.rsnhope.org/kidney-disease-advocacy/the-chronic-kidney-disease-improvement-in-research-and-treatment-act-of-2019-s-1676/, this is what the act provides:

“Specifically, the legislation does the following:

  • Medigap available to all ESRD Medicare beneficiaries, regardless of age.
  • Improve care coordination for people on dialysis by requiring hospitals to provide an individual’s health and treatment information to their renal dialysis facility upon their discharge. The individual or dialysis facility may initiate the request.
  • Increase awareness, expand preventative services, and improve coordination of the Medicare Kidney Disease Education program by allowing dialysis facilities to provide kidney disease education service. And it will allow physician assistants, nurse practitioners, and clinical nurse specialists, in addition to physicians, to refer patients to the program. And additionally, provide access to these services to Medicare beneficiaries with Stage 5 (CKD) not yet on dialysis.
  • Incentivize innovation for cutting-edge new drugs, biologicals, devices, and other technologies by maintaining an economically stable dialysis infrastructure. The Secretary would be required to establish a process for identifying and determining appropriate payment amounts for incorporating new devices and technologies into the bundle.
  • Improve the accuracy and transparency of ESRD Quality Programs so patients can make better decisions about their care providers.
  • Improve patient understanding of palliative care usage as well as access to palliative care services in underserved areas.
  • Allow individuals with kidney failure to retain access to private insurance plans as their primary payor for 42 months, allowing people to keep their private plans longer.”

I scooted over to EurekAlert! at https://www.eurekalert.org/pub_releases/2019-04/uoo-bkd041219.php when I realized they were announcing a drug I’d blogged about:

“’A drug like canagliflozin that improves both cardiovascular and renal outcomes has been eagerly sought by both patients with Type 2 diabetes and clinicians caring for them,’ added Kenneth Mahaffey, MD, professor of medicine at the Stanford University School of Medicine and co-principal investigator of the trial. ‘Now, patients with diabetes have a promising option to guard against one of the most severe risks of their condition.’

The researchers found the drug canagliflozin, a sodium glucose transporter 2 (SGLT2) inhibitor, was less effective at lowering blood sugar in people with reduced kidney function but still led to less kidney failure, heart failure and cardiovascular events such as heart attacks, strokes and death from cardiovascular disease.

Professor Perkovic said the results were impressive. ‘The substantial benefit on kidney failure despite limited effects on blood glucose suggest that these drugs work in a number of different ways beyond their effects on blood sugar. This is an area of intense ongoing research.’”

These are just a few of the innovations in kidney disease in 2019. I hope to see many more for us – like the FDA approval of the artificial kidney – in 2020.

Until next year,

Keep living your life!

Dapagliflozin/SGLT2 inhibitors

I’ve been reading a lot about dapagliflozin lately. That’s a word I didn’t know. And this is the perfect opportunity to learn about it. Ready? Let’s start.

The obvious first stop to my way of thinking was Medline Plus, part of the U.S. Library of Medicine, which in turn, is part of the Institutes of National Health at https://medlineplus.gov/druginfo/meds/a614015.html.

“Dapagliflozin is used along with diet and exercise, and sometimes with other medications, to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Dapagliflozin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking dapagliflozin, making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.”

SGLT2 inhibitors? Hey, that was going to be next week’s blog… or so ignorant me thought. The Food and Drug Administration (FDA) at https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/sodium-glucose-cotransporter-2-sglt2-inhibitors explains what a SGLT2 inhibitor is.

“SGLT2 inhibitors are a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. Medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, and empagliflozin. They are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type 1 diabetes, and FDA has not approved them for use in these patients.”

There are also quite a few warnings about amputations and urinary tract infections caused by SGLT2 inhibitors on this site, although they are dated 8/20/18.

 

So it seems that dapagliflozin is one of several medications classified as SGLT2 inhibitor. So let’s concentrate on SGLT2s inhibitors then. Hmmm, is this some medication requiring injections or do you just pop a pill? Pharmacy Times at https://www.pharmacytimes.com/publications/health-system-edition/2014/september2014/sglt2-inhibitors-a-new-treatment-option-for-type-2-diabetes more than answered my question. It’s their chart you see above this paragraph.

Wait a minute. According to their chart, dapagliflozin is not recommended if your GFR is below 60, or stage 3 CKD. Canagliflozin is not recommended if your GFR is below 45. Your kidney function is a big factor in whether or not this drug can be prescribed for you.

But why? Exactly how do the kidneys process this drug? The following diagram from The National Center for Biotechnology Information, part of the U.S. National Library, which in turn (again) is part of the National Institutes of Health at https://www.ncbi.nlm.nih.gov/core/lw/2.0/html/tileshop_pmc/tileshop_pmc_inline.html?title=Click%20on%20image%20to%20zoom&p=PMC3&id=3889318_13300_2013_42_Fig1_HTML.jpg will give you the visual. Basically, the SLGT2 inhibitor prevents the glucose in your blood from re-entering your blood stream after your blood has been filtered. The glucose has nowhere to go, so it exits your body via your urine along with the other wastes.

What about the side effects, since we already know the limitations of prescribing SLTG2 inhibitors? I thought  WebMd at  https://www.medicinenet.com/sglt2_inhibitors_type_2_diabetes_drug_class/article.htm#how_do_sglt2_inhibitors_work might enlighten us and they certainly did.

”On Aug. 29, 2018, the FDA issued a warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called SGLT2 inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene.

SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type 2 diabetes. SGLT2 inhibitors lower blood sugar by causing the kidneys to remove sugar from the body through the urine. First approved in 2013, medicines in the SGLT2 inhibitor class include canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin. In addition, empagliflozin is approved to lower the risk of death from heart attack and stroke in adults with type 2 diabetes and heart disease. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

Seek medical attention immediately if you experience any symptoms of tenderness, redness, or swelling of the genitals or the area from the genitals back to the rectum, and have a fever above 100.4 F or a general feeling of being unwell. These symptoms can worsen quickly, so it is important to seek treatment right away.

On May 15, 2015, the FDA informed the public that SGLT2 inhibitors have been associated with increased risk of ketoacidosis in people with diabetes.

Common side effects

The most common side effect of SGLT2 inhibitors include:

Serious side effects of SGLT2 inhibitors include:

Whoa. It looks like there will have to be some serious discussions with your nephrologist before you agree to taking a SLGT2 inhibitor should he or she suggest it. Make sure you have your list of questions ready and someone to listen carefully and take notes.

Until next week,

Keep living your life!