TIDMAZN
RNS Number : 6661B
AstraZeneca PLC
24 September 2018
This announcement contains inside information
24 September 2018 07:00 BST
Farxiga achieved a positive result in the Phase III DECLARE-TIMI
58 trial, a large cardiovascular outcomes trial in 17,000 patients
with type-2 diabetes
Farxiga met the primary composite endpoint of a
statistically-significant reduction
in hospitalisation for heart failure or CV death in a broad
patient population
Results confirmed the well-established safety profile of
Farxiga
AstraZeneca today announced positive results from the Phase III
DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for
Farxiga (dapagliflozin), the broadest SGLT2 inhibitor CVOT
conducted to date. The trial evaluated the CV outcomes of Farxiga
vs. placebo over a period of up to five years, across 33 countries
and in more than 17,000 adults with type-2 diabetes (T2D) who have
multiple CV risk factors or established CV disease.
In the DECLARE (Dapagliflozin Effect on Cardiovascular
Events)-TIMI 58 trial, Farxiga met its primary safety endpoint of
non-inferiority for major adverse cardiovascular events (MACE).
Farxiga achieved a statistically-significant reduction in the
composite endpoint of hospitalisation for heart failure (hHF) or CV
death, one of the two primary efficacy endpoints. Additionally,
fewer MACE events were observed with Farxiga for the other primary
efficacy endpoint, however, this did not reach statistical
significance.
Data from DECLARE-TIMI 58 confirmed the well-established safety
profile of Farxiga.
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal
and Metabolism, Global Medicines Development said: "Farxiga has
achieved a statistically-significant and clinically-important
reduction in hospitalisation for heart failure or CV death in a
broad range of patients with type-2 diabetes and cardiovascular
risk. The results from this landmark trial are especially important
since heart failure is an early and frequent complication of
diabetes and associated with hospitalisations that result in a
considerable societal and economic burden." (1-7)
Dr Stephen Wiviott of Brigham and Women's Hospital and Harvard
Medical School, a senior investigator with the Thrombolysis in
Myocardial Infarction (TIMI) study group and co-principal
investigator of the trial, commented: "The DECLARE-TIMI 58 results
offer compelling evidence that dapagliflozin helps to address an
important medical need among a diverse group of patients with
type-2 diabetes by reducing the composite of hospitalisation for
heart failure or CV death, with a safety profile supportive of
broad use."
Detailed trial results will be presented on 10 November at the
American Heart Association Scientific Sessions 2018 in Chicago,
USA.
About DECLARE-TIMI 58
DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58
is an AstraZeneca-sponsored, randomised, double-blinded,
placebo-controlled, multicentre trial 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 was
independently run in collaboration with academic investigators from
the TIMI study group (Boston, USA) and the Hadassah Hebrew
University Medical Center (Jerusalem, Israel).(8)
DECLARE is part of the extensive DapaCare clinical programme for
Farxiga, which will enrol patients in randomised clinical trials,
including a wide range of mechanistic studies, and is supported by
a multinational real-world evidence study (CVD-REAL). The DapaCare
clinical programme will generate data across a spectrum of people
with CV risk factors, established CV disease and varying stages of
renal disease, both with and without T2D. DECLARE is paving the way
for three Phase III trials: Dapa-HF, DELIVER and Dapa-CKD.
About Farxiga (dapagliflozin)
Farxiga is a first-in-class, oral, once-daily selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2)
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control, with the additional benefits of weight
loss and blood pressure reduction, as an adjunct to diet and
exercise in adults with T2D. Farxiga is not indicated to reduce the
risk of CV events, CV death or hHF. Farxiga has a robust clinical
trial programme of more than 35 completed and ongoing Phase IIb/III
trials in over 35,000 patients, as well as more than 1.8 million
patient-years' experience.
About AstraZeneca in Cardiovascular, Renal & Metabolism
(CVRM)
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. Our ambition is to
modify or halt the natural course of CVRM diseases and potentially
regenerate organs and restore 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
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.
For more information, please visit www.astrazeneca.com and
follow us on Twitter @AstraZeneca.
Media Relations
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AstraZeneca PLC
References
1. International Diabetes Federation, IDF Diabetes Atlas, Eighth Edition Update, 2017.
2. Shah AD, Langenberg C, Rapsomaniki E, et al. Type 2 diabetes
and incidence of cardiovascular diseases: a cohort study in 1--9
million people. Lancet Diabetes Endocrinol. 2015;3:105-113.
3. Faden, et al. The increasing detection of asymptomatic left
ventricular dysfunction in patients with type 2 diabetes mellitus
without overt cardiac disease: Data from the SHORTWAVE study.
Diabetes Res Clin Pract. 2013;101(3):309-16.
4. Low Wang, Cecilia C. et al. "Atherosclerotic Cardiovascular
Disease and Heart Failure in Type 2 Diabetes - Mechanisms,
Management, and Clinical Considerations." Circulation 133.24
(2016): 2459-2502. PMC. Web. 19 Sept. 2018.
5. Heidenreich, Paul A. et al. "Forecasting the Impact of Heart
Failure in the United States: A Policy Statement From the American
Heart Association." Circulation. Heart failure 6.3 (2013): 606-619.
PMC. Web. 19 Sept. 2018.
6. Nichols GA, Brown JB: The impact of cardiovascular disease on
medical care costs in subjects with and without type 2 diabetes.
Diabetes Care 25:482-486, 2002.
7. Nichols, et al. The incidence of congestive heart failure in
type 2 diabetes. Diabetes Care, Volume 27, Number 8, Aug. 2004:
http://care.diabetesjournals.org/content/27/8/1879.
8. Multicenter Trial to Evaluate the Effect of Dapagliflozin on
the Incidence of Cardiovascular Events (DECLARE-TIMI 58). Sept.
2018. https://clinicaltrials.gov/ct2/show/NCT01730534.
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END
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