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Research Outline
Prepared for Bryan B. | Delivered October 8, 2019
Entresto Overview
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Goals
Obtain information on the background and timeline of the Entresto drug. The information will be used to understand more about the history of the drug.
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Early Findings
ENTRESTO DRUG OVERVIEW
Entresto
includes the sacubitril and valsartan compounds.
Sacubitril
is a blood pressure drug that elevates the concentration of specific body proteins to expand the blood vessels.
This can then
lower sodium levels
and enable the reduction of blood pressure.
Meanwhile,
Valsartan is an "angiotensin
II receptor blocker (sometimes called an ARB)."
The compound
prevents the blood vessels
from constricting to help in lowering blood pressure and facilitating blood flow.
Entresto
is recommended for certain patients with chronic heart diseases.
The drug can
reduce hospitalization frequencies
when the patients' heart condition worsen.
Entresto
can also help reduce the mortality risk from heart diseases.
It is usually
prescribed with other
blood pressure drugs.
ENTRESTO APPROVAL HISTORY
On August 27, 2012, the "
new Novartis Phase II data
" indicated that LCZ696 may have a positive clinical impact on patients with severe cases of heart disease.
On August 30, 2014, it was proven in a landmark PARADIGM-HF trial that the drug slashes cardiovascular
mortality instances by 20%
as compared to the ACE-inhibitor.
On November 17. 2014,
nine new studies
revealed that the drug has the power to alter the course of heart disease in patients.
By February 13, 2015, the drug got an
FDA priority review
.
Entresto was
first approved
by the FDA last July 7. 2015.
Its previous name was
LCZ696
and it comes in tablets.
The drug is manufactured by the
Novartis Pharmaceuticals Corporation
.
The approval of the drug was "based on results from the
8,442-patient PARADIGM-HF study
" which was ceased early when it was proven that Entresto greatly lowered the risk of cardiovascular mortality and hospital confinements that are linked to heart failure as compared to the ACE-inhibitor enalapril.
Insights on the safety data revealed that Entresto had the
same tolerability level
as enalapril.
However, in the recent "
Paragon-HF phase 3
clinical trials," Entresto has "narrowly
missed its primary endpoint
in a trial of patients with preserved ejection fraction (HFpEF)."
The trial
missed to show the statistical importance
of its main objective of lowering cardiovascular mortality and overall heart failure confinements.
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