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AstraZeneca PLC | NYSE:AZN | NYSE | Depository Receipt |
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Comprehensive updated analysis provides valuable evidence on the safety profile of Farxiga, including no imbalance in lower-limb amputations
New analyses from CVD-REAL examine reductions in CV events for SGLT-2 inhibitors, including Farxiga in patients with and without CV disease versus DPP-4 inhibitors
AstraZeneca presented new data at the American Diabetes Association’s (ADA) 77th Scientific Sessions underpinning the safety profile of Farxiga (dapagliflozin) with an analysis of data pooled from dapagliflozin clinical trials, as well as three new cardiovascular (CV) outcomes analyses from the ongoing CVD-REAL study, the first large real-world evidence study of its kind evaluating treatment with SGLT-2 inhibitors (SGLT-2i), including dapagliflozin.
In an updated safety analysis, data pooled from 30 Phase IIb/III clinical trials for dapagliflozin showed no new safety signals and the incidence of adverse events was generally similar to that in the control groups. Importantly, there was no imbalance in lower-limb amputations, with eight (0.1%) patients and seven (0.2%) patients identified in the dapagliflozin and control groups, respectively.
Following the primary publication of the CVD-REAL study in May 2017, three new analyses presented at ADA add to the ongoing evaluation of earlier treatment with SGLT-2is and in broader patient populations with type-2 diabetes (T2D). The analyses evaluated effects in additional real-world patient populations, including CV endpoints specific to dapagliflozin:
Elisabeth Bjrk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said: “SGLT-2 inhibitors are being prescribed with greater frequency for patients with type-2 diabetes, so it is vital that we have a clear understanding of the safety profile of these medicines and examine their effectiveness in a real-world setting. The data we are presenting at ADA underpins the safety of Farxiga and highlights the potential for earlier use of the SGLT-2 inhibitor class, and in broader patient populations than originally understood.”
The CVD-REAL study is ongoing and future analyses will be conducted using this dataset as well as data from additional countries. The data for the study were obtained from anonymized real-world sources including medical records, claims databases and national registries, 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, USA. 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 is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Farxiga is not indicated to reduce the risk of CV events, death or hospitalization for heart failure. 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
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
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.
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NOTES TO EDITORS
About the DapaCare Clinical Program
AstraZeneca is taking a holistic, patient-centric approach to disease management by focusing on the underlying morbidity, mortality and organ damage associated with cardiovascular (CV), metabolic and renal diseases. Due to the interconnectivity of these diseases, AstraZeneca has developed the DapaCare clinical programme to explore the CV and renal profile of dapagliflozin in people with and without type-2 diabetes. The clinical programme will enroll nearly 30,000 patients in randomized clinical trials and is supported by a multinational real-world evidence study. DapaCare will generate data across a spectrum of people with established CV disease, CV risk factors and varying stages of renal disease, both with and without type-2 diabetes, providing healthcare providers with evidence needed to potentially improve patient outcomes. DapaCare underscores our commitment to following the science by pursuing a holistic patient approach to address the multiple risk factors associated with CV, metabolic and renal diseases. Dapagliflozin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Dapagliflozin is not indicated for the treatment of other metabolic diseases, to reduce the risk of cardiovascular disease or renal disease.
About AstraZeneca in Cardiovascular & Metabolic Diseases (CVMD)
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. Recognizing 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170612005430/en/
AstraZenecaMedia InquiriesMichele Meixell, +1 302-885-2677orAlex Engel, +1 302-885-2677
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