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FARXIGA significantly reduced hospitalization for heart failure or CV death in a wide patient population with type 2 diabetes in the DECLARE-TIMI 58 trial




WILMINGTON, PART .– ( BUSINESS WIRE ) – AstraZeneca announced positive positive results from DECLARE-TIMI today
58 cardiovascular (CV) outcome test (CVOT) for FARXIGA
(Dapagliflozin). The data was presented as a delayed abstract
(# 19485) at the American Heart Association (AHA) Scientific Sessions
2018 in Chicago, IL, and at the same time published in New
England's Journal of Medicine
(NEJM). 1

Results from DECLARE-TIMI 58, the largest SGLT-2 inhibitor (SGLT-2i)
CVOT performed to date, including more than 17,000 patients across 33
The countries showed that FARXIGA reduced the risk
hospitalization for heart failure (hHF) or CV-death composite vs.
placebo by 17% (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73-0.95] p = 0.005), a
of the two primary efficacy endpoints. Reduction in hHF or CV death
was consistent throughout the patient population, which included
those with CV risk factors and those with established CV diseases. 1 FARXIGA
is not indicated to reduce the risk of CV events or hHF.

In addition, there were fewer major unwelcome cardiovascular events
(MACE) observed with FARXIGA for the second primary effect point,
However, this did not come to statistical significance (8.8% for FARXIGA
vs 9.4% for placebo; HR 0.93 [95% CI 0.84-1.03] p = 0.17).

DECLARE-TIMI 58 also confirmed the well-established security profile for
FARXIGA, who met the primary security endpoint for non-inferiority vs.
placebo, which shows no increase in the composite of MACE, defined as
CV death, heart attack (heart attack) or stroke. 1

Further to other relevant safety measures, the experiment showed no
imbalance with FARXIGA vs placebo in amputations (1.4% vs. 1.3%),
fractures (5.3% vs. 5.1%), bladder cancer (0.3% vs. 0.5%) or fourniers
gangrene (1 case vs 5 cases). The respective occurrence of diabetics
ketoacidosis (0.3% vs. 0.1%) and gender infections (0.9% vs. 0.1%) were
rare. 1

Elisabeth Björk, vice president, leader of cardiovascular, kidney and
Metabolism, Global Medicines Development, said: " These positive results
is clinically relevant to the 425 million people worldwide live with
diabetes, of which those with type 2 diabetes have two to five times
Greater risk of heart failure together with increased cardiovascular risk
attack or stroke. Heart rate survival rates are only 50% after five
Year after diagnosis, and therefore these new findings are so important
In expanding our understanding of how we go beyond blood sugar we saw
can better address this serious and often overlooked cardiovascular
complication. " 2-6

Although secondary endpoints were only nominally significant,
Composite endpoint showed that FARXIGA reduced the frequency of new or
worsened nephropathy by 24% vs. placebo over the wide
patient population studied (4.3% vs. 5.6%, HR 0.76 [95% CI 0.67-0.87]),
and there were fewer causes of mortality with FARXIGA vs. placebo
(6.2% vs. 6.6%; HR 0.93 [95% CI 0.82-1.04]). 1 FARXIGA is not
indicated to reduce the risk of HF, other CV outcomes, nephropathy or
all-cause mortality.

INDICATION AND RESTRICTIONS FOR USE OF FARXIGA (dapagliflozin) tablets
5 mg and 10 mg

FARXIGA is indicated as a supplement to diet and exercise to improve
glycemic control in adults with diabetes mellitus type 2.

FARXIGA is not recommended for patients with diabetes mellitus type 1 or
for the treatment of diabetic ketoacidosis.

IMPORTANT SAFETY INFORMATION FOR FARXIGA

Contraindications

  • Earlier severe hypersensitivity reaction to FARXIGA
  • Serious renal impairment (eGFR <30 ml / min / 1.73 m 2 ),
    End-stage renal disease, or patients in dialysis

Warnings and Precautions

  • Hypotension: FARXIGA causes intravascular volume contraction,
    and symptomatic hypotension may occur. Rate and correct volume
    status before FARXIGA is initiated in patients with renal impairment
    function, elderly patients, or patients on loop diuretics. Monitor for
    hypotension
  • Ketoacidosis has been reported in patients of type 1 and
    Type 2 diabetes receives FARXIGA. Some cases were fatal. consider
    Patients presenting signs and symptoms of metabolic acidosis for
    ketoacidosis, independent of blood sugar levels. If you suspect,
    end FARXIGA, evaluate and treat immediately. Before you start
    FARXIGA, assess risk factors for ketoacidosis. Patients at FARXIGA
    may require monitoring and temporary cessation in situations
    known to predispose for ketoacidosis
  • Acute renal injury and renal impairment: FARXIGA
    causing intravascular volume contraction and impaired kidney function, with
    reports of acute renal injury requiring hospitalization and dialysis.
    Consider temporarily interrupting settings with reduced oral intake
    or fluid loss. If acute renal injury occurs, interrupt and
    promptly process.
    FARXIGA increases serum creatinine and decreases
    EGFR. Older patients and patients with renal impairment may
    Be more prone to these changes. Before you start FARXIGA,
    Assess kidney function and monitor regularly. FARXIGA is not
    is recommended in patients with eGFR persistent between 30 and <60
    ml / min / 1.73 m 2
  • Urosepsia and Pyelonephritis: SGLT2 inhibitors increase
    risk of urinary tract infections [UTIs] and severe UTI has been
    reported with FARXIGA. Consider the signs and symptoms of UTI and
    treat immediately
  • Hypoglycaemia: FARXIGA may increase the risk of hypoglycaemia
    when administered with insulin and insulin secretaries. Consider
    decrease in the dose of these agents when administered together with FARXIGA
  • Nekrotizing fasciitis of the perineum (Fournier's Gangrene):
    Rare but serious life-threatening cases have been reported in
    patients receiving SGLT2 inhibitors, including FARXIGA. Things have been
    reported in women and men. Serious outcomes have included
    hospitalization, operations and death. Consider patients presenting with
    pain or tenderness, erythema, swelling of the sex or perineal
    area, along with fever or discomfort. If you suspect it, you must ask
    treatment and discontinuation of FARXIGA.
  • Genital Mycotic Infections: FARXIGA increases the risk of
    genital mycotic infections, especially in patients with earlier
    genital mycotic infections. Monitor and treat properly
  • Low-density lipoprotein cholesterol increases (LDL-C) occur
    with FARXIGA. Monitor LDL-C and treat per standard for care
  • Bladder cancer: An imbalance in bladder cancer was observed in
    clinical studies. There were too few cases to decide on
    The emergence of these events is related to FARXIGA, and insufficient data
    to determine if FARXIGA has an effect on existing bladder
    tumors. FARXIGA should not be used in patients with active bladder
    cancer. Use with caution in patients with bladder cancer history
  • Macrovascular Outcomes: There have been no clinical studies
    Establishing vital evidence of macrovascular risk reduction with
    FARXIGA

Side Effects

In a pool with 12 placebo-controlled studies, the most common harmful
reactions (≥ 5%) associated with FARXIGA 5 mg, 10 mg and placebo
respectively, female sexual 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

  • Pregnancy: Provide Women with Potential Risk of Fetal
    especially during the second and third trimesters.
  • Breastfeeding: FARXIGA is not recommended when breastfeeding

Please read US
Full Prescribing Information
and Medication
Guide
for FARXIGA

NOTES TO EDITORS

About DECLARE-TIMI 58

DECLARE (Dapagliflozin Effect on Cardiovascular Events) -TIMI-58 is a
AstraZeneca-sponsored, randomized, double-blind, placebo-controlled,
multicenter test designed to evaluate the effect of FARXIGA compared
with placebo on CV outcomes in adults with T2D at risk of CV events,
including patients with multiple CV risk factors or established CV
disease. DECLARE included more than 17,000 patients across 882 sites in
33 countries and were independently run in cooperation with academics
investigators from the TIMI study group (Boston, USA) and Hadassah
Hebrew University Medical Center (Jerusalem, Israel).

About DapaCare

DECLARE is part of the comprehensive clinical DapaCare program for FARXIGA,
which will record patients in randomized clinical studies, including a
wide range of mechanistic studies, and supported by a multinational
real-world proof study (CVD-REAL). DapaCare clinical program will
generate data across people with CV risk factors,
established CV disease and varying stages of kidney disease, both with
and without T2D. DECLARE paves the way for three Phase III attempts:
Dapa-HF, DELIVER and Dapa-CKD.

About AstraZeneca in Cardiovascular, Renal and Metabolism (CVMD)

Cardiovascular, renal and metabolic diseases together form one of
AstraZeneca's main therapy areas and platforms for future growth. Of
follow the science to understand the underlying links more clearly
between the heart, the kidney and the pancreas, AstraZeneca invests in a
portfolio of medicines to protect organs and improve results by slowing down
disease progression, reducing risks and coping with morbidities. our
Ambition is to modify or stop the natural extension of CVMD diseases and
even regenerate organs and restore the function by continuing to deliver
transformative science that improves treatment practices and
cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global science-led biopharmaceutical company like
focuses on discovery, development and commercialization of
prescription drugs, primarily for treating diseases in wood
Therapy Areas – Oncology, Cardiovascular, Kidney and Metabolism and
Respiratory system. The company is also selectively active within the areas
autoimmunity, neuroscience and infection. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. For more information, visit http://www.astrazeneca-us.com
and follow us on Twitter @AstraZenecaUS.

References

1. Wiviott SD, et al. Dapagliflozin and Cardiovascular outcome in Type
2 diabetes. New England Journal of Medicine. 2018 Nov. DOI:
10.1056 / NEJMoa181289
2. International Diabetes Federation. IDF Diabetes Atlas, 8th Edition.
Brussels, Belgium: International Diabetes Association; 2017.
Available at http://www.diabetesatlas.org/resources/2017-atlas.html.
Access 10 November 2018
3. Low Wang CC, Hess CNm Hiatt WR, et al. Clinical Update:
Cardiovascular disease in diabetes mellitus atherosclerotic
Cardiovascular disease and heart failure in type 2 diabetes mellitus
– Mechanisms, management and clinical considerations. Circulation.
2016 June 14th; 133 (24): 2459-502
4. Wu Y, Ding Y, Tanaka Y, et al. Risk factors contributing to Type 2
Diabetes and recent advances in treatment and prevention. Int.
J. Med. Sci. 2014; 11 (11): 1185-1200.
5. Nichols et al. The incidence of congestive heart failure in type 2
diabetes. Diabetes Care. 2004 aug; 27 (8): 1879-84
6. Roger VL. Epidemiology of heart failure. Circulation Research.
2013; 113: 646-659



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