Tag Archives: empagliflozin

FDA Says Jardiance Can Be Marketed as Cardiovascular Death-Defying

Jardiance is a diabetes drug in the class called SGLT2 inhibitors.

How do they work? Our kidneys filter glucose (sugar) out of our bloodstream, then reabsorb that glucose back into the bloodstream. SGLT2 inhibitors impair that reabsorption process, allowing some glucose to be excreted in our urine. You could call it a diuretic effect. For example, an SGLT 2 inhibitor called dapagliflozin, at a dose of 10 mg/day, causes the urinary loss of 70 grams of glucose daily.

How drugs like this could prevent cardiovascular disease in type 2 diabetics is a mystery to me.

From MPT:

“The diabetes drug empagliflozin (Jardiance) may be marketed for prevention of cardiovascular death in patients with type 2 diabetes and co-existing cardiovascular disease, the FDA said Friday.

It’s the first such claim ever allowed for a diabetes drug.

Empagliflozin, first approved in 2014, is an inhibitor of the sodium-glucose co-transporter 2 (SGLT2) pathway, reducing blood glucose by causing it to be excreted in urine.Its benefit for cardiovascular risk reduction was demonstrated in the so-called EMPA-REG trial, results of which were reported in 2015.”

Source: Jardiance Wins CV Prevention Indication | Medpage Today

Are These Two Diabetes Drugs Better Than the Others?

Better living through chemistry

Empagliflozin is a pill. Liraglutide is a once-daily subcutaneous injection.

The two drugs in question are empagliflozin (aka Jardiance) and liraglutide (aka Victoza). Both are used to treat type 2 diabetes, not type 1.

A major problem we have with most diabetes drugs is that while they do lower blood sugars, we don’t have much evidence on whether they actually prolong life and prevent bad outcomes like heart attacks, strokes, cancer, blindness, kidney failure, amputations, and serious infections.

It gets even more complicated. For instance, a given drug may eventually be proven to prolong life by a year via prevention of death from heart disease, while at the same time increasing the risk of spending that last year bedridden from a stroke.

It’s extremely difficult and costly to suss out these issues. It requires large clinical trials wherein half of the PWDs (people with diabetes) are treated with a particular drug, and the other half are treated with “standard therapy.” Five or 10 years later you compare clinical endpoints between the two groups. A couple studies have done this recently.

A blogger I follow, Larry Husten, wrote the following:

But it was the secondary goal of these trials that led to the transformation of the field. Baked into the trial design was the provision that if they were able to establish noninferiority then the trial investigators were permitted to test for superiority. The second phase began when Empa-Reg became the first trial to convincingly show a clear benefit, including a reduction in cardiovascular death and a reduction in hospitalization for heart failure. with empagliflozin (Jardiance, Merck). Then, more recently, the LEADER trial showed a significant reduction in cardiovascular events with liraglutide (Victoza, Novo Nordisk). In both trials nearly all the patients had significant established cardiovascular disease—precisely the population that cardiologists are likely to see.

Click the embedded links above for more details. Even better, read the original research reports if you have the time and knowledge. I support my family with a full-time job taking care of patients, so it will be a while (if ever) before I can dig into this further. (When my book sales make me independently wealthy, I’ll have more time for this!)

diabetic diet, low-carb Mediterranean Diet, low-carb, Conquer Diabetes and Prediabetes

Analyzing clinical reports requires a good grasp of logic, statistics, and basic science

Are the LEADER and Empa-Reg trials valid? Yeah, maybe. In an ideal world, other investigators would try to replicate the results with additional clinical trials. Are the published results free of fraud and bias? I don’t know.

Because we don’t know the long-term effects of many of our diabetes drugs, I favor doing as much as possible to control blood sugars with diet, exercise, and weight management.

Stay tuned for future developments.

Steve Parker, M.D.

PS: Just because one drug in a class of drugs reduces bad clinical outcomes, it doesn’t mean all drugs in the class do.

PPS: If it’s hard for you to pronounce empagliflozin and liraglutide, some of my books don’t even have them.

Does Diabetes Drug Empagliflozin Reduce Heart Disease Risk?

diabetic mediterranean diet, Steve Parker MD

Pharmacist using her advanced degree to count pills

Larry Husten writing at CardioBrief mentions a recent press release alleging that empagliflozin reduces cardiovascular disease risk.

Larry points out a problem with diabetes drugs that I’ve been harping on for years: we don’t know the long-term outcomes and side effects of most of our drugs. As long as a diabetes drug reduces blood sugar and seems to be relatively safe in the short term, it will be approved for use by the U.S. Food and Drug Administration. Larry writes:

Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical benefit.

Cardiovascular disease is a major stalker of diabetics. I’m talking about heart attacks, strokes, heart failure, sudden cardiac death.

The aforementioned press release touts reduced cardiovascular disease risk in patients taking empagliflozin. What’s missing is any mention of overall death reduction. Even if the drug really prevents heart attacks and strokes, which I doubt, don’t you want to know about overall death rates? I do. For all we know, the drug could promote illness and death from infections and cancer while reducing heart attacks and strokes. The drug’s net effect could be premature death. 

I’m 99% certain the researchers doing the work have the mortality data. Unless they don’t want to know.

By no means am I against drug use. But if I had type 2 diabetes, I’d do all I can with exercise, weight control, and low-carb eating before resorting to new or higher doses of drugs.

Steve Parker, M.D.