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- SGLT2 inhibitors have
been very exciting drugs.
They were originally developed
for the treatment of diabetes,
but in large-scale
cardiovascular outcome trials,
the major benefit of these drugs
was not just to lower blood glucose,
but to actually prevent the
progression of heart failure
and the progression of renal disease.
These were really remarkable effects,
had nothing to do with their
ability to lower blood glucose.
And we and others got really
excited about using these drugs
in patients with
established heart failure,
already getting optimal medical therapy,
and to determine if it would
add to existing treatments.
One year ago, a trial called DAPA-HF
studied an SGLT2 inhibitor, dapagliflozin,
in patients with a heart failure
and reduced ejection fraction
with or without diabetes.
And they reported a reduction
in cardiovascular death
and hospitalization for heart failure
with dapagliflozin in that trial.
Our trial is the Emperor-Reduced trial
and our trial is in many
ways similar to DAPA-HF.
We studied heart failure with
a reduced ejection fraction
with or without diabetes,
but we studied patients who
had more severe disease.
About 70, 75% of our patients
had an ejection fraction
of 30% or less.
And they were all getting
all appropriate treatments
for heart failure.
20% were getting neprilysin inhibitors.
We randomized patients
to either get placebo
or empagliflozin, 10
milligrams once daily,
and we followed them for
an average of 16 months.
Now it's very, very important to realize
that we designed this trial
to have only three endpoints,
three major outcome measures.
And they were ranked in
a hierarchical manner.
I want to show you and talk
to you about the results
on these three endpoints.
First, the primary endpoint,
empagliflozin reduced the risk
of cardiovascular death
and hospitalization
for heart failure by 25%.
The second endpoint,
total hospitalizations,
first and recurrent
hospitalizations for heart failure,
empagliflozin reduced the risk by 30%.
A third endpoint, which
was our kidney endpoint.
This was the slope in decline of estimated
glomerular filtration rate over time,
empagliflozin significantly slowed
the deterioration in renal function.
And very importantly, it reduced the risk
of a serious kidney event by 50%.
In all three circumstances,
the effect was clinically important
and it was highly significant.
Each one of these endpoints was reached
with a p-value of less than 0.001.
So we were very excited
about these results.
The drug was exceptionally well tolerated,
none of the traditional side effects
of drugs for heart failure,
such as hypotension,
bradycardiac, kidney issues, hyperkalemia.
These were not things
that we saw with this drug
in this trial.
So this trial strongly
reinforces the results
of the DAPA-HF trial.
When you put your two trials together,
they established the firm basis
of using SGLT2 inhibitors,
dapagliflozin or empagliflozin,
for the treatment of heart failure,
with a reduced ejection fraction
with or without diabetes
on top of all existing
treatments for heart failure,
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