154. SGLT2, Mindfulness, Pill on a String

https://www.acpjournals.org/doi/10.7326/M20-2470

Pharmacologic Approaches to Glycemic Treatment of Type 2 Diabetes: Synopsis of the 2020 American Diabetes Association's Standards of Medical Care in Diabetes Clinical Guideline
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Which is as the artciel suggest in a sypnopsis of the 2020 ADA guidelines


metformin is still universal fist line but now the guideline says

The choice of agent to add to metformin therapy should be individualized on the basis of patient characteristics, preferences, and drug-specific effects.

The big rec from this paper is
Among patients with type 2 diabetes who have established ASCVD or established kidney disease, or heart failure, a sodium–glucose cotransporter-2 (SGLT2) inhibitor or glucagon-like peptide-1 receptor agonist (GLP-1 RA) with demonstrated cardiovascular disease benefit is recommended (Grade A recommendation).

they go on to say maybe one of the key lines--------The addition of these medications should be considered independent from HbA1c level in this patient population.

You might remember dapaggliflozin – the article last year that I said was one of the top articles of the year because it changed how we practice for both diabetes and heart failure!! Well now---I give you--- https://www.nejm.org/doi/10.1056/NEJMoa2022190

Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure in the NEJM

EMPEROR-Reduced trial recently out which looked to see if empagliclozin could join dapagliflozin for risk reduction in heart failure!!
This was a double-blind, randomized, placebo-controlled, using empagliflozin (10 mg daily)


At a mean follow-up of 16 months, patients receiving empagliflozin had a lower risk for the primary endpoint of cardiovascular death or hospitalization for worsening HF than placebo recipients with a shocking NNT of 20 although this was mainly driven by heart failure hospitalizations these numbers are similar to dapagliflozin -- (19.4% vs. 24.7%). –AND THIS was INDEPENDENT OF DIABETIC DIAGNOSIS!! AND when you looked at the change in A1C at the end of the trial—there was no difference, just maybe these SGLT2 inhibitors really are people drugs, not diabetic drugs which has to make everyone question the relevance of the surrogate marker we use for diabetes, A1C.

not to go on too much of a rant but if we look at A1C and say this is the standard by which all drugs should be measured and some drugs DO NOT CHANGE THE A1C or at least not with any clinical significance but they do prevent death, MI and hospisitliations while other drugs dont change any of the hard outcomes but they change the A1C we have to say maybe just maybe A1C is not the marker we should care about.
and as excited as I am abou the rush of evidence around SGLT2 inhibitors.
Sadly the best medication is likely still prevention, with healthy lifestyle- these drugs are still around $500 a month so we are talking at least 6grand a year for a drug that 95 out of 100 people will never benefit from. Which means we are talking roughly 120,000$ per event saved! So I grant you this is a really impressive article and empagliflozin is now joining dapagliflozin to prevent heart failure hospitalistizations, and I still think the SGLT-2 inhibitors are quickly becoming king of the castle for diabetes treatment—I also think they will never truly take the thrown till they are $4 a month like metformin.

next article

And while talking guidelines

Synopsis of the 2020 U.S. Department of Veterans Affairs/U.S. Department of Defense Clinical Practice Guideline: The Diagnosis and Management of Hypertension in the Primary Care Setting
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Also in annals of internal medicine but had a couple interesting or new recommendations like

we suggest using attended or unattended, fully automated blood pressure measurement. A fully automated BP programmed to wait 5 minutes and recod the average of threee measurements separated by at least 30 seconds
there goal bp is <130
unless you are 60yrs old and older then <150
but If you are 60yrs and older AND DM then <140

with any of the main medication- ACE, ARB, CC, thiazide and if they are on 3 or more of these medications then it is resistant and give spironolactone

nothing too shocking in this paper but just a good refresher and something to keep in mind, and speaking of keeping in mind!!


Seminowicz DA, Burrowes SA, Kearson A, et al. Enhanced mindfulness-based stress reduction in episodic migraine: a randomized clinical trial with magnetic resonance imaging outcomes. Pain 2020;161(8):1837-1846.


this RCT of almost 100 people recruited mostly white women who had on average about 8 headaches a month and 85% were not on prophylaxis medications
pts were enrolled in either mindfulness-based stress reduction classes or stress management for headaches classes. The classes met weekly for 8 weeks, then biweekly for another 8 weeks.
Those in the mindfulness classes went from 8 headaches a month down to 5 and those in the stress management classes went down to 7. So there was a much bigger difference in the group randomized to mindfulness classes. You might be saying this is a really small reduction in headaches to only go from 8 to 5 and at 1 year of follow up there was no difference, which is likely because the people stopped doing mindfulness. However I will remind you the treatment we have for headaches is some of the worst in medicine. We pass and prescribe drugs all the time that reduce your month headache burdon by 1 or 2 and part of what makes treating headaches so difficult is the mental aspect which is why placebo does so well in most trials.
a paper
Verhagen AP, Damen L, Berger MY, Passchier J, Koes BW. Lack of benefit for prophylactic drugs of tension-type headache in adults: a systematic review. Fam Pract 2010;27(2):151-165.
which was a systematic review looking at prophylaxis treatment of tension headaches. They looked at antidepressants, muscle relaxants, benzodiazepines, or vasodilators
and found There is no evidence -- or only poor quality -- that any of these prophylactic agents are effective for tension-type headaches

so keep in mind while a mindfulness course might night sound like a good headache treatment plan, it might be the best thing we have…..

effective as prophylaxis for patients with frequent tension headaches?

and while this podcast might be torture to your eardrums this last article should fall under torture and stupid-

Fitzgerald RC, di Pietro M, O'Donovan M, et al. Cytosponge-trefoil factor 3 versus usual care to identify Barrett's oesophagus in a primary care setting: a multicentre, pragmatic, randomised controlled trial. Lancet 2020;396(10247):333-344.

which was a nonblinded trial that looked to see if swallowing a special sponge to sample esophageal epithelial cells for biomarker testing identify patients with Barrett's esophagus in primary care settings?
basically is it possible to diagnose BE in the outpatient primary care setting. the authors enrolled patients at least 50 years old who had received H2 receptor antagonists or proton pump inhibitors for at least 6 months in the previous year. The researchers randomized the patients to receive usual care which was continue acid surpression and maybe an EGD if the provider felt like it OR they would undergo this toture office-based screening. In total around 1500 patients underwent this torture procedure. before I tell you what the procedure was I will say that 89% of the patients felt the procedure was tolerable but while getting a foley cath is technically tolerable I would want one and while getting a rectal tube is tolerable, no….no thank you. soo

the intervention consisted of swallowing a capsule containing a sponge attached to a thread. After the patient swallows the capsule, the nurse yanks on the thread and pulls out the sponge and sends it for analysis looking at a couple markers found in the gut to tell us if the patient had barrients esophogus.
YOU SWALLOWED A PILL THEN JUST A NURSE PULL IT BACK OUT OF YOUR FROM WITH A STRING---THIS IS A PILL ON A STRING!!!!!

The results did show that who that had this string torture procedure were diagnosed more often, twice as often. The usual care was diagnosed with BE around 1% and the tampon string pill people were diagnosed with it a whopping 2% of the time. You were 2x as likely to be diagnosed with BE!!!
2 TIME AS LIKELY!!!
BUT we always have to ask whats the outcome… BE means nothing without cancer. afib means nothing without a stroke.
well the rate of BE turning to cancer is RARE- a cohort study titled
Hvid-Jensen F, Pedersen L, Drewes AM, Sørensen HT, Funch-Jensen P. Incidence of adenocarcinoma among patients with Barrett's esophagus. N Engl J Med 2011;365(15):1375-1383.
estimated an annual incidence of esophageal cancer to be LOW, real LOW they say--
Barrett's esophagus is a strong risk factor for esophageal adenocarcinoma, but the absolute annual risk, 0.12%, is much lower than the assumed risk of 0.5%, which is the basis for current surveillance guidelines. Data from the current study call into question the rationale for ongoing surveillance in patients who have Barrett's esophagus without dysplasia.