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EventsThe first drug to reduce mortality in type 2 diabetes revealed! And it’s low carb in a pill!
How the drug works
Finally there’s a drug that can help people with type 2 diabetes live longer and healthier lives.
As incredible as it sounds most drugs in type 2 diabetes – like insulin – only helps to control blood sugar. They don’t actually improve the disease or help patients live longer. Sometimes they even make things worse.
Yesterday at the huge diabetes conference in Stockholm that changed. Results from a large trial shows that the drug Jardiance can help people with diabetes get less heart disease AND live longer (besides lowering blood sugar, blood pressure and even helping people to lose weight).
- NYT: Jardiance, a Diabetes Drug, Cut Cardiovascular Deaths by 38%, Study Says
- LATimes: Diabetes drug drives down fatal heart attacks, strokes, study finds
This is massive news for anybody interested in type 2 diabetes. And it makes perfect sense.
While other drugs are trying to hide the problem in type 2 diabetes (too much sugar in the body), Jardiance and other similar SGLT2-inhibitor drugs try to get rid of the problem. They increase the loss of glucose via the urine, by making people pee out up to 70 grams per day of the carbohydrates they eat.
Of course you can get a much stronger effect – and avoid all of the side effects – by simply not eating the carbohydrates in the first place. But hey, nobody can make money selling that. Read free advice on how to do it.
Earlier
I wrote about a similar drug (Farxiga) two years ago: Low-Carb Diet in a Pill – A Good Idea?
I may have mentioned it before, maybe here or somewhere else: what are the consequences of chronically elevated glucose levels in the bladder and connecting 'pipework'? I would imagine it to be a perfect habitat for all sorts of potentially nasty microorganisms: watery solution, warm, food & drink for free. Kidney infections don't sound appealing to me, at all.
If I had to choose for myself, I'd probably go for a bit of Metformin + strict low-carb / keto. After a while the Metformin might not be needed anymore.
But hopefully a step in the right direction for more people to understand the obviously very complicated fact that if you have a disease that gives you too high blood sugar levels, you just might need to cut back on sugar and carbohydrates...
https://m.facebook.com/AmericanDiabetesAssociation/posts/101531406183...
Wow!
We need to rise up and let them (ADA or whatever organization is in your country) know the diet they're recommending does not seem to work and in fact makes things worse. When they start seeing that there are many, many N=1 arguments against their diet and for a low carb diet, perhaps they'll begin to change. The optimist in me hopes so. The pessimist thinks they'll ignore this outpouring.
There are the results:
Results
A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events.
http://www.nejm.org/doi/full/10.1056/NEJMoa1504720?query=featured_hom...;
For some reason, they put a lot more people in the group under test and not as many in the placebo group. Not sure why that is. I don't have time now to calculate actual risk, but will see if I can do so later.
What happens to a1c levels and ketones?
Could a low dose increase the effectiveness of high fat diet.
?
What about non diabetics?
Eric
Meanwhile, while diabetes cannot be treated with drugs that mask the problem, using drugs to reduce blood sugars does have the benefit of reducing your risk of damage through high blood sugar. LCHF and IF are a great way to treat the insulin resistance and therefore the diabetes. By itself, this drug would be just another mask but I believe we in this community who are 'hard cases' can use it to good effect until our BG levels are normalised and then, yippee, we can be drug free.
This LCHF has been the most hopeful WOL I've experienced in years. What a great community, and this blog and links are compulsive reading for me, Andreas.
The common focus on reduction in glucose and HbA1c, while interesting is just sales talk. The real game is disease prevention.
My blood sugar is high due to Cushings and this drug didn't help much at all, and gave me a horrible cough that lingered for months after I stopped taking it.
(Before you jump in the band wagon, that even the Diet Doctor seem to has fallen. These type of drugs do very little to lower blood glucose because one of the side effects is increased gluconeogenesis, not good for a diabetic liver. Not to mention urinary track infections, vaginal infections and possible bladder cancer.)
Cutting through the Jardiance Study Hype: Be Cautious with this Drug!
http://diabetesupdate.blogspot.com/2015/09/cutting-through-jardiance-...
Today's diabetes news is focusing on a study, published in the New England Journal of Medicine where the press release states:
Results after a median follow-up of about three years illustrated that patients receiving Jardiance had a 14-percent lower rate of the primary composite outcome than did those in the placebo group. Specifically, the drug was associated with a significant 38-percent lower rate of death from CV causes, while no significant difference was noted in the risks of non-fatal heart attack or non-fatal stroke. Meanwhile, patients treated with Jardiance also had significantly reduced rates of heart failure hospitalisations and death from any cause, with relative risk reductions of 35 percent and 32 percent, respectively.
If this is true, it would be logical for doctors to put all their patients with diabetes on this drug, but closer inspection of the actual published study made it very clear to me that it was far from true, and that the actual statistics had been heavily massaged to achieve the final numbers published.
Here's what the actual study reports:
1. The study was conducted only in people diagnosed with diabetes and established cardiovascular disease. That was defined as people who had already had a heart attack, stroke, stenting, unstable angina or a failed stress test. So these were people who were already quite ill with heart disease. Not your average person with well-controlled diabetes.
2. The drug, Jardiance (Empaglifozin) did a poor job of lowering the blood sugar of these people, whose starting A1c ranged from 7% to 10%. "At week 94, the adjusted mean differences in the glycated hemoglobin level between patients receiving empagliflozin and those receiving placebo were -0.42 percentage points and -0.47 percentage points respectively; at week 206, the differences were -0.24 percentage points and -0.36 percentage points." The two numbers refer to the two doses. At the end of the study the average A1c was 7.81 in those taking the drug. This suggests (though the standard deviation isn't given) so it is hard to know where the blood sugars clustered. This still means that means that a lot of people had A1cs north of 8%.
3. More people had fatal strokes while taking Jardiance than while taking the placebo. More people had nonfatal strokes while taking Jardiance than while taking placebo This data is on page 45 of the appendix to the study. More people taking Jardiance also had silent myocardial infarctions (heart attacks) on Jardiance than in the placebo group. More people were hospitalized for unstable angina on the lower dose of Jardiance than on placebo and the higher doses was pretty close to placebo.
4. Sub Group analysis showed that Blacks, people with better kidney function, people with A1cs over 8.5%, those with peripheral artery disease, and those on insulin did better on the placebo. (I.e. not taking the drug.) People over 65 were borderline for doing better on placebo.
5. A relatively small number of these people who were seriously impacted by cardiovascular disease actually died or had a serious adverse event in both groups. The actual difference in the number of deaths was an improvement of about 3% in the group as a whole--ie. out of every hundred 3 more people survived. This isn't trivial, but it is quite different from the inflated "risk" statistics being publicized that inflate the numbers. Basically if you have serious heart disease and take this drug, your chance of having a heart attack or heart failure goes down, while your chance of having a fatal or nonfatal stroke goes up.
6. One quarter of those who participated in the trial dropped out. Many had adverse events, the most common of which was a genital infection (i.e. yeast.) These were much more common among women than men, and far higher in the group taking Jardiance than the placebo group. One in ten women on the drug had a significant genital infection. I have heard anecdotally that these infections are very painful and extremely hard to clear up, even after the drug is discontinued.
This suggests to me that if you have had a heart attack this might be a drug worth considering, though if you are concerned about stroke or have a history suggesting it is a possibility, you might want to avoid it.
But if you haven't been diagnosed with heart attack or stented, you might want to think twice and concentrate instead on lowering your A1c. There is a clear cut relationship between A1c and heart attack risk and an A1c of 8% correlates to a much higher risk than one in the 5% range. You can't get to the 5% range with this drug, which is likely to lower your A1c a quarter of a percent. You can by cutting out carbs and, if that doesn't work because your beta cells no longer are making any insulin, finding a doctor who will give you an effective insulin regimen (basal and bolus.)
But as we all know, doctors are far too busy and overburdened to actually read this study and think through all the reported results. They will read newsletters that provide summaries instead. So all they will hear is that 38% risk improvement and the prescriptions will be written for everyone with Type 2 diabetes--and some for people with Type 1, as there is a movement afoot to promote this drug for Type 1, too.
This may end up causing unnecessary, life-destroying strokes in people who needed never have them.
Be careful!
We already know from the ACCORD, ADVANCE and VADT trials that great blood glucose lowering does NOT necessarily lead to better health, in fact sometimes it's dangerous (ACCORD).
Recommending insulin treatment to hyperinsulinemic type 2 diabetics after the ACCORD trial in particular seem not just wrong but clearly dangerous.
In type 2 diabetes the best treatments seem to be focused on getting the excess sugar out of the body, not just out of the blood (and into other already over-loaded tissues). This drug is a perfect example.
"Of course you can get a much stronger effect – and avoid all of the side effects – by simply not eating the carbohydrates in the first place. But hey, nobody can make money selling that. "
Now, that comment I agree with 100%.
Kind regards Eddie
stop eating carbs. not low carb which is great but not perfect, but no carbs.
at some point, the cells will release the sugars in the body.....
many people have more than diabetes....they have other issues for which fasting is not recommended....
Sorry but I'm not impressed by the increased UTIs and thrush (been there, don't want to go there again) and pissing your bones down the toilet along with the excess glucose. The only drug I'd seriously consider is metformin which actually addresses metabolism in several ways, from the mitochondria on up.
By eating the exact opposite of what the dietician told me was a "healthy diet" not only did my BG fall into normal range but my IR fell through the floor (trigs/HDL went from nearly 7 to under 1 and has stayed there for over a decade now), and I lost the 15kg she made me gain. I used "test test test" to control my postprandial BG and the rest just fell into line. IF this starts to fail I will consider metformin, then possibly postprandial insulin (I lack Phase 1 insulin but so far my Phase 2 is holding up well).
I accept I'm going to die prematurely due to doctors choosing not to take my symptoms seriously for the first 50 years of my life, I'd rather do so quickly of a heart attack or stroke than slowly from cancer with bits missing. Or spend years on dialysis, I suspect long term use of this stuff may lead to kidney damage.
It MAY have a valid niche market but I suspect it will be widely touted and do more harm than good.
Sure it sounds like low carb in a pill but if you eat the carbs you still get the insulin response don't you?
Low carbohidrate intake is free, is healthy and safe money.