Curriculum Vitae Vs Resume The Shocking Revelation Of Curriculum Vitae Vs Resume

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today appear absolute abounding after-effects from the DECLARE-TIMI 58 cardiovascular (CV) outcomes balloon (CVOT) for FARXIGA (dapagliflozin). The abstracts were presented as a late-breaking abstruse (#19485) at the American Affection Association (AHA) Scientific Sessions 2018 in Chicago, IL, and accompanying appear in the New England Journal of Medicine (NEJM).1



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After-effects from DECLARE-TIMI 58, the bigger SGLT-2 inhibitor (SGLT-2i) CVOT conducted to date, including added than 17,000 patients above 33 countries, showed that FARXIGA decidedly bargain the accident of analysis for affection abortion (hHF) or CV afterlife blended vs. placebo by 17% (4.9% vs. 5.8%; HR 0.83 [95% CI 0.73-0.95], p=0.005), one of the two primary ability endpoints. The abridgement in hHF or CV afterlife was constant above the absolute accommodating population, which included those with CV accident factors and those with accustomed CV disease.1 FARXIGA is not adumbrated to abate the accident of CV contest or hHF.



Additionally, there were beneath above adverse cardiovascular contest (MACE) empiric with FARXIGA for the added primary ability endpoint, about this did not ability statistical acceptation (8.8% for FARXIGA vs. 9.4% for placebo; HR 0.93 [95% CI 0.84-1.03], p=0.17).1

DECLARE-TIMI 58 additionally accepted the absolute assurance contour for FARXIGA, which met the primary assurance endpoint of non-inferiority vs. placebo, demonstrating no access in the blended of MACE, authentic as CV death, affection advance (myocardial infarction), or stroke.1



Further, on added accordant assurance measures, the balloon showed no alterity with FARXIGA vs. placebo in amputations (1.4% vs. 1.3%), fractures (5.3% vs. 5.1%), float blight (0.3% vs. 0.5%) or Fournier’s adulteration (1 case vs. 5 cases). The corresponding incidences of diabetic ketoacidosis (0.3% vs. 0.1%) and animal infections (0.9% vs. 0.1%) were rare.1

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Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, All-around Medicines Development, said: “These absolute after-effects are clinically accordant to the 425 actor bodies accepted alive with diabetes, of whom those with blazon 2 diabetes accept a two-to-five times greater accident of affection abortion forth with an added accident of a affection advance or stroke. Affection abortion adaptation ante are alone 50% afterwards bristles years from diagnosis, which is why these new allegation are so important in adorning our compassionate of how to go above claret glucose so we may bigger abode this austere and generally disregarded cardiovascular complication.”2-6

Although accessory endpoints were alone nominally significant, the renal blended endpoint showed that FARXIGA bargain the amount of new or deepening nephropathyby 24% vs. placebo above the ample accommodating citizenry advised (4.3% vs. 5.6%; HR 0.76 [95% CI 0.67-0.87]), and there were beneath all-cause bloodshed contest with FARXIGA vs. placebo (6.2% vs. 6.6%; HR 0.93 [95% CI 0.82-1.04]).1 FARXIGA is not adumbrated to abate the accident of HF, added CV outcomes, nephropathy or all-cause mortality.

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

FARXIGA is adumbrated as an accessory to diet and exercise to advance glycemic ascendancy in adults with blazon 2 diabetes mellitus.

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

IMPORTANT SAFETY INFORMATION FOR FARXIGA

Contraindications

Warnings and Precautions

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Adverse Reactions

In a basin of 12 placebo-controlled studies, the best accepted adverse reactions (≥5%) associated with FARXIGA 5 mg, 10 mg, and placebo appropriately were changeable animal mycotic infections (8.4% vs. 6.9% vs. 1.5%), nasopharyngitis (6.6% vs. 6.3% vs. 6.2%), and urinary amplitude infections (5.7% vs. 4.3% vs. 3.7%).

Use in Specific Populations

Amuse read US Abounding Prescribing Information and Medication Guide for FARXIGA

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NOTES TO EDITORS

About DECLARE-TIMI 58

DECLARE (Dapagliflozin Aftereffect on Cardiovascular Events)-TIMI-58 is an AstraZeneca-sponsored, randomized, double-blinded, placebo-controlled, multicenter balloon advised to appraise the aftereffect of FARXIGA compared with placebo on CV outcomes in adults with T2D at accident of CV events, including patients with assorted CV accident factors or accustomed CV disease. DECLARE included added than 17,000 patients above 882 sites in 33 countries and was apart run in accord with bookish board from the TIMI abstraction accumulation (Boston, USA) and the Hadassah Hebrew University Medical Center (Jerusalem, Israel).

About DapaCare

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DECLARE is allotment of the all-encompassing DapaCare analytic affairs for FARXIGA, which will accept patients in randomized analytic trials, including a advanced ambit of mechanistic studies, and is accurate by a bunch real-world affirmation abstraction (CVD-REAL). The DapaCare analytic affairs will accomplish abstracts above a spectrum of bodies with CV accident factors, accustomed CV ache and capricious stages of renal disease, both with and after T2D. DECLARE is paving the way for three Phase III trials: Dapa-HF, DELIVER and Dapa-CKD.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVMD)

Cardiovascular, renal and metabolic diseases calm anatomy one of AstraZeneca’s capital analysis areas and platforms for approaching growth. By afterward the science to accept added acutely the basal links amid the heart, branch and pancreas, AstraZeneca is advance in a portfolio of medicines to assure organs and advance outcomes by slowing ache progression, abbreviation risks and arrest co-morbidities. Our appetite is to adapt or arrest the accustomed advance of CVMD diseases and alike change organs and restore function, by continuing to bear transformative science that improves analysis practices and cardiovascular bloom for millions of patients worldwide.

About AstraZeneca

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AstraZeneca is a global, science-led biopharmaceutical aggregation that focuses on the discovery, development and commercialization of decree medicines, primarily for the analysis of diseases in three analysis areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Aggregation additionally is selectively alive in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its avant-garde medicines are acclimated by millions of patients worldwide. For added information, amuse appointment http://www.astrazeneca-us.com and chase us on Twitter @AstraZenecaUS.

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