Landmark real-world evidence from an
international study of more than 300,000 patients with type-2
diabetes showed treatment with SGLT-2 inhibitors reduced risk of
hospitalization for heart failure by 39% and all-cause mortality by
51%
CVD-REAL data are presented at the American
College of Cardiology 66th Annual Scientific Session
AstraZeneca today announced results of the first large
real-world evidence study of its kind evaluating the risk of
hospitalization for heart failure and death from any cause in
patients with type-2 diabetes (T2D) receiving treatment with a
newer class of diabetes medicines, SGLT-2 inhibitors (SGLT-2i).
The CVD-REAL study assessed data from more than 300,000 patients
across six countries, 87% of whom did not have a history of
cardiovascular disease. The data showed that across this broad
population of patients with T2D compared to other T2D medicines,
treatment with SGLT-2i medicines - Farxiga (dapagliflozin),
canagliflozin, empagliflozin - reduced the rate of hospitalization
for heart failure by 39% (HR 0.61; 95% CI 0.51-0.73; p<0.001)
and death from any cause by 51% (HR 0.49; 95% CI 0.41-0.57;
p<0.001). For the composite endpoint of hospitalization for
heart failure and death from any cause, the reduction was 46% (HR
0.54; 95% CI 0.48-0.60; p<0.001).
Worldwide, diabetes affects around 415 million adults, a number
estimated to rise to 642 million by 2040 (1 in 10 adults). People
with T2D have a 2-3 times greater risk of heart failure and are at
an increased risk of having a heart attack or stroke, and some 50%
of deaths in people with T2D are caused by cardiovascular
disease.
Bruce Cooper, MD, Vice President and Head of Global Medical
Affairs at AstraZeneca, said: “Diabetes is a growing epidemic
worldwide, which is associated with significant comorbidities that
contribute to an increased risk of costly hospitalizations and even
death. Real-world data from this study provide striking evidence
that the newer SGLT-2i class of medicines cuts the rate of
hospitalizations for heart failure and death by approximately half.
CVD-REAL is the first study to observe these effects of SGLT-2i
treatment in a much broader and lower risk group of type-2 diabetes
patients than previously evaluated in clinical trials.”
The hospitalizations for heart failure analysis was conducted
using anonymized patient data from Denmark, Germany, Norway,
Sweden, United Kingdom and the United States. Of the data reviewed,
41.8% of patients were on Farxiga (dapagliflozin), 52.7% on
canagliflozin and 5.5% on empagliflozin. The analysis of death from
any cause was conducted using anonymized patient data from Denmark,
Norway, Sweden, United Kingdom and the United States. Of the data
reviewed, 51.0% of patients were on Farxiga (dapagliflozin), 42.3%
on canagliflozin and 6.7% on empagliflozin.
This is the first of several comparative analyses of CVD-REAL.
The study is ongoing and future analyses will be conducted using
this dataset as well as data from additional countries. The data
for this study were obtained from real-world sources including
medical records, claims databases and national registers, and were
not independently adjudicated or verified against source documents.
The analysis was validated by the independent academic statistical
group at St. Luke’s Mid America Heart Institute, Kansas City, US.
While CVD-REAL was a large study with a robust propensity-matching
technique, given its observational nature the possibility of
residual, unmeasured confounding factors cannot be definitively
excluded.
Farxiga (dapagliflozin) is indicated as an adjunct to diet and
exercise to improve glycemic control in adults with type-2
diabetes. Farxiga is not indicated to reduce the risk of CV events,
death or hospitalization for heart failure. There have been no
clinical trials establishing conclusive evidence of macrovascular
risk reduction with Farxiga. The dapagliflozin cardiovascular
outcomes trial, DECLARE, is ongoing and expected to provide
data in 2019 at the latest.
Important Safety Information for FARXIGA®
(dapagliflozin)
Contraindications
- Prior serious hypersensitivity reaction
to FARXIGA
- Severe renal impairment (eGFR <30
mL/min/1.73 m2), end-stage renal disease, or patients on
dialysis
Warnings and Precautions
- Hypotension: FARXIGA causes
intravascular volume contraction, and symptomatic hypotension can
occur. Assess and correct volume status before initiating FARXIGA
in patients with impaired renal function, elderly patients, or
patients on loop diuretics. Monitor for hypotension
- Ketoacidosis has been reported
in patients with type 1 and type 2 diabetes receiving FARXIGA. Some
cases were fatal. Assess patients who present with signs and
symptoms of metabolic acidosis for ketoacidosis, regardless of
blood glucose level. If suspected, discontinue FARXIGA, evaluate
and treat promptly. Before initiating FARXIGA, consider risk
factors for ketoacidosis. Patients on FARXIGA may require
monitoring and temporary discontinuation in situations known to
predispose to ketoacidosis
- Acute Kidney Injury and Impairment
in Renal Function: FARXIGA causes intravascular volume
contraction and renal impairment, with reports of acute kidney
injury requiring hospitalization and dialysis. Consider temporarily
discontinuing in settings of reduced oral intake or fluid losses.
If acute kidney injury occurs, discontinue and promptly
treat.FARXIGA increases serum creatinine and decreases eGFR.
Elderly patients and patients with impaired renal function may be
more susceptible to these changes. Before initiating FARXIGA,
evaluate renal function and monitor periodically. FARXIGA is not
recommended in patients with an eGFR persistently between 30 and
<60 mL/min/1.73 m2
- Urosepsis and Pyelonephritis:
SGLT2 inhibitors increase the risk for urinary tract infections
[UTIs] and serious UTIs have been reported with FARXIGA. Evaluate
for signs and symptoms of UTIs and treat promptly
- Hypoglycemia: FARXIGA can
increase the risk of hypoglycemia when coadministered with insulin
and insulin secretagogues. Consider lowering the dose of these
agents when coadministered with FARXIGA
- Genital Mycotic Infections:
FARXIGA increases the risk of genital mycotic infections,
particularly in patients with prior genital mycotic infections.
Monitor and treat appropriately
- Increases in Low-Density Lipoprotein
Cholesterol (LDL-C) occur with FARXIGA. Monitor LDL-C and treat
per standard of care
- Bladder cancer: An imbalance in
bladder cancers was observed in clinical trials. There were too few
cases to determine whether the emergence of these events is related
to FARXIGA, and insufficient data to determine whether FARXIGA has
an effect on preexisting bladder tumors. FARXIGA should not be used
in patients with active bladder cancer. Use with caution in
patients with a history of bladder cancer
- Macrovascular Outcomes: There
have been no clinical studies establishing conclusive evidence of
macrovascular risk reduction with FARXIGA
Adverse Reactions
In a pool of 12 placebo-controlled studies, the most common
adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and
placebo respectively were female genital mycotic infections (8.4%
vs 6.9% vs 1.5%), nasopharyngitis (6.6% vs 6.3% vs 6.2%), and
urinary tract infections (5.7% vs 4.3% vs 3.7%).
Use in Specific Populations
- Pregnant Women: There are no
adequate and well-controlled studies of FARXIGA in pregnant women.
Consider appropriate alternative therapies, especially during the
second and third trimesters. Use during pregnancy only if the
potential benefit justifies the potential risk to the fetus
- Nursing Mothers: Discontinue
FARXIGA or discontinue nursing
Indication and Limitations of Use for FARXIGA®
(dapagliflozin)
FARXIGA is indicated as an adjunct to diet and exercise to
improve glycemic control in adults with type 2 diabetes mellitus.
FARXIGA is not recommended for patients with type 1 diabetes
mellitus or for the treatment of diabetic ketoacidosis.
Please see accompanying US Full Prescribing
Information and Medication Guide for FARXIGA.
NOTES TO EDITORS
About SGLT-2 inhibitors
Dapagliflozin (marketed as Farxiga in the US and Forxiga outside
the US) is part of a class of medicines called sodium-glucose
cotransporter 2 inhibitors (SGLT-2i) used to manage type-2
diabetes, which remove glucose via the kidneys.
About Dapagliflozin Clinical Trials Program
There are three ongoing outcomes trials for dapagliflozin.
DECLARE is a robust randomized, double-blind, multicenter,
placebo-controlled cardiovascular outcomes trial enrolling more
than 17,000 patients around the world, designed to evaluate the
cardiovascular outcomes of dapagliflozin compared with placebo in
addition to standard of care, in adults with T2D and high risk of
cardiovascular disease (either established cardiovascular disease
or multiple cardiovascular risk factors). DECLARE is ongoing and
expected to provide data in 2019 at the latest. In addition to
DECLARE, AstraZeneca has initiated two outcomes trials, the DAPA-HF
and DAPA-CKD trials, to help to define the potential role of
dapagliflozin in the management of chronic heart failure and
chronic kidney disease respectively, in people with and without
type-2 diabetes. Dapagliflozin is not indicated to reduce the risk
of cardiovascular events, death, heart failure or the progression
of chronic kidney disease.
About AstraZeneca in Cardiovascular and Metabolic
Diseases
Cardiovascular, renal and metabolic diseases are key areas of
focus for AstraZeneca as part of the company’s strategy for
achieving scientific leadership and returning to growth. By
collaborating across therapeutic disciplines within the CVMD
therapy area, we are addressing the underlying disorders that drive
CVMD risk, with the goal of reducing morbidity, mortality and organ
damage through innovative therapies. Recognising the growing unmet
needs and challenges faced by the millions of people worldwide
living with these interrelated diseases, we are determined to
understand how they interact and impact one another – and how they
can be treated together to save more patients’ lives.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit www.astrazeneca-us.com and follow us on Twitter
@AstraZenecaUS.
3334500 Last Updated 3/17
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170319005050/en/
AstraZenecaMichele Meixell, +1 302-885-2677orAbigail Bozarth, +1
302-885-2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024