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Business Wire 1-Nov-2018 7:00 AM
New data on cardiovascular effects of long-term BRILINTA use in patients with a history of heart attack
Data from 20 abstracts further highlight AstraZeneca's holistic approach to care in cardiovascular, renal and metabolic diseases
AstraZeneca will present 20 abstracts including a late-breaking oral presentation on the full results from the Phase III cardiovascular (CV) outcomes trial (CVOT) DECLARE (Dapagliflozin Effect on Cardiovascular Events)-TIMI 58, the broadest SGLT2 inhibitor CVOT conducted to date, as well as new research from the Company's Cardiovascular, Renal & Metabolism (CVMD) therapy area at the American Heart Association (AHA) Scientific Sessions, November 10-12, 2018, in Chicago, Illinois, USA.
New evidence will build on broad clinical research from AstraZeneca that aims to help redefine the management of CVMD diseases and address the need for a more proactive and holistic approach to patient care. Presentations will include findings from some of the largest trials in broad patient populations with FARXIGA (dapagliflozin) in type 2 diabetes (T2D), BRILINTA (ticagrelor) in patients with a history of heart attack, and in hyperkalemia.
Danilo Verge, Vice President, Cardiovascular, Renal & Metabolism, Global Medical Affairs, said: "An estimated 20 million people each year die from cardiovascular, renal and metabolic diseases, yet shared risk factors are frequently not diagnosed or addressed holistically.1,2,3 Our data at AHA reflect an integrated approach to managing the needs of patients living with type 2 diabetes and risk of cardiovascular or renal disease, and those with a history of cardiovascular disease at acute and long-term risk of recurrence. We stand firmly behind our mission to provide new solutions earlier in disease management to these patients at risk for multiple complications."
DECLARE-TIMI 58: a landmark CVOT evaluating CV risk in patients with T2D
Clinical trial results showing the safety and efficacy of FARXIGA vs. placebo on primary CV and secondary renal efficacy outcomes in adults with T2D who have multiple CV risk factors or established CV disease, will be presented in a late-breaking oral presentation (Late Breaking Abstract #19485). DECLARE-TIMI 58 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 T2D with multiple CV risk factors or established CV disease.
In September 2018, AstraZeneca announced that FARXIGA met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE) and achieved a statistically-significant reduction in the composite endpoint of hospitalization 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. Clinical trial results presented at AHA Scientific Sessions 2018 will include additional details on the primary CV safety and efficacy, as well as secondary renal efficacy outcomes from DECLARE-TIMI 58. FARXIGA is not indicated to reduce the risk of CV events, hHF or renal outcomes.
Three new sub-analyses from the PEGASUS-TIMI 54 trial will also be presented. The trial compared BRILINTA (90mg or 60mg twice daily) plus aspirin vs. aspirin alone in 21,162 patients with prior (1 to 3 years) heart attack. The sub-analyses evaluate:
Data will also be presented on potential risk factors for repeated or persistent hyperkalemia (Poster # SuMDP65).
Key abstracts at the AHA Scientific Sessions 2018:
Abstract title | Presentation details | |
FARXIGA | ||
The Dapagliflozin Effect on CardiovascularEvents (DECLARE)–TIMI 58 Trial |
Late Breaking Abstract #19485 Saturday November 10, 3:45 PM - 4:00 PM Session: LBS.02. Late Breaking Clinical Trial:Novel Approaches to CV Prevention |
BRILINTA | ||
Long-Term Secondary Prevention with Ticagrelorfor Prior Myocardial Infarction in Patients with noCoronary Stenting: A Sub-analysis fromPEGASUS TIMI 54
|
Oral Presentation #102Sunday November 11, 4:15 PM - 4:25 PM Session: AC.AOS.01, S103bc. Advances inthe Prediction and Modification ofCardiovascular Disease Risk |
|
High-sensitivity Cardiac Troponin at AnyDetectable Concentration Identifies Higher Riskof Major Cardiovascular Events in Patients withStable Ischemic Heart Disease |
Oral Presentation #100 November 11, 3:45 PM - 3:55 PM Session: AC.AOS.01, S103bc. Advances inthe Prediction and Modification ofCardiovascular Disease Risk |
|
Method of Assessing Medication Persistenceand Clinical Outcomes: A Comparison of PatientReport and Pharmacy Fill Data from theARTEMIS Trial |
Oral Presentation #452 November 11, 2:45 PM - 2:50 PM Session: QU.RFO1. ACS Top QCORAbstracts: Rapid Fire |
|
Impact of Coronary Artery Disease Severity onRisk of Cardiovascular Disease in Type 2Diabetes Patients: A Swedish NationwideObservational Study |
Poster # Su1297, 1297 November 11, 10:30 AM - 11:45 AM Session: QU.APS.03. Acute and ChronicCoronary Artery Disease: Quality Care andOutcomes |
|
Patient Selection for Long-Term Prevention ofLimb Ischemic Events |
Oral Presentation (Rapid Fire) #419 November 10, 2:15 PM - 3:30 PM Session: VA.RFO1. Understanding Risk andMechanisms of Critical Limb Ischemia:Lessons from the Long CLImb |
|
Patient Selection for Long-Term SecondaryPrevention with Ticagrelor: Insights fromPEGASUS-TIMI 54 |
Poster #Sa2100, 2100 November 10, 2:15 PM - 3:30 PM Session: AC.APS.09. Pharmacotherapy inACS and Stable Ischemic Heart Disease |
|
Caffeine and Dyspnea With Ticagrelor: A Sub-analysis From PEGASUS TIMI-54 Trial |
Poster #2097, Sa2097 November 10, 2:15 PM - 3:30 PM Session: AC.APS.09. Pharmacotherapy inACS and Stable Ischemic Heart Disease |
|
The 'Halo Effect" of a P2Y12 InhibitorCopayment Reduction Intervention onAdherence and Persistence with otherCardiovascular medications: Results from theARTEMIS Cluster Randomized Trial |
Poster #Sa2098, 2098 November 10, 2:15 PM - 3:30 PM Session: AC.APS.09. Pharmacotherapy inACS and Stable Ischemic Heart Disease |
|
Hyperkalemia | ||
What Characterizes the Patients who DevelopRepeated or Persistent Hyperkalemia? |
Poster # SuMDP65 November 11, 11:45 AM - 12:55 PM Session: HF.MDP2. Interesting Topics inHeart Failure and Cardiomyopathy |
The full list of scientific data can be accessed on the AHA 2018 Online Planner here. You can also follow us live during the event on Twitter and LinkedIn.
INDICATION AND LIMITATIONS OF USE FOR FARXIGA (dapagliflozin) tablets 5 mg and 10 mg
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.
IMPORTANT SAFETY INFORMATION FOR FARXIGA
Contraindications
Warnings and Precautions
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
Please read US Full Prescribing Information and Medication Guide for FARXIGA
IMPORTANT SAFETY INFORMATION FOR BRILINTA (ticagrelor) 60-MG AND 90-MG TABLETS
WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
A. BLEEDING RISK
B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
ADVERSE REACTIONS
DRUG INTERACTIONS
INDICATIONS FOR BRILINTA
BRILINTA is indicated to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction. For at least the first 12 months following ACS, it is superior to clopidogrel.
BRILINTA also reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS.
DOSING
In the management of ACS, initiate BRILINTA treatment with a 180-mg loading dose. Administer 90 mg twice daily during the first year after an ACS event. After one year administer 60 mg twice daily. Use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.
Patients can find out more information about BRILINTA at www.BRILINTA.com or by calling 1-888-412-7454.
Please read full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.
NOTES TO EDITORS
About AstraZeneca in Cardiovascular, Renal & Metabolism (CVMD)
Cardiovascular, renal and metabolic diseases together form one of AstraZeneca's main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney 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 CVMD diseases and even 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 commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism 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 http://www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.
References
1. World Health Organization. Cardiovascular Disease: World Heart Day 2017 Accessed October 29, 2018. http://www.who.int/cardiovascular_diseases/world-heart-day-2017/en/.
2. Wang H et al. Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980–2015: A systematic analysis for the Global Burden of Disease Study 2015. The Lancet 2016; 388(10053):1459–544. https://doi.org/10.1016/S0140-6736(16)31012-1.
3. Ogurtsova K et al. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract 2017; 128:40–50. https://doi.org/10.1016/j.diabres.2017.03.024.
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