{"id":14607,"date":"2020-07-05T07:28:53","date_gmt":"2020-07-05T07:28:53","guid":{"rendered":"https:\/\/yourchennai.com\/?p=14607"},"modified":"2020-07-05T07:28:53","modified_gmt":"2020-07-05T07:28:53","slug":"astrazenecas-dapagliflozin-forxiga-approved-in-india-for-treatment-of-patients-with-heart-failure","status":"publish","type":"post","link":"https:\/\/yourchennai.com\/index.php\/2020\/07\/05\/astrazenecas-dapagliflozin-forxiga-approved-in-india-for-treatment-of-patients-with-heart-failure\/","title":{"rendered":"AstraZeneca\u2019s Dapagliflozin (Forxiga) approved in India for treatment of patients with Heart Failure"},"content":{"rendered":"
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Dapagliflozin (Forxiga) is the first SGLT-2 inhibitor proven to significantly reduce the risk of Cardiovascular death and hospitalisation for heart failure in patients with HFrEF<\/strong>.<\/p>\n

AstraZeneca Pharma India Limited (AstraZeneca India), a leading science-led biopharmaceutical company, today received the Marketing Authorization for Dapagliflozin (Forxiga),\u00a0 for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). This is the first in class SGLT-2 inhibitor drug approved for the treatment of\u00a0 HFrEF and is the first drug proven to significantly reduce the risk of Cardiovascular death and hospitalisation for Heart Failure in patients with HFrEF.<\/p>\n

The approval follows positive results from the landmark Phase III DAPA-HF trial,\u00a0 that proved that Dapagliflozin in addition to standard of care, reduced the risk of the composite outcome of Cardiovascular death or the worsening of Heart Failure versus placebo by 26%.1\u00a0\u00a0 <\/sup>About one-fourth patients in the study population were\u00a0 from Asian region including India.<\/p>\n

\"AstraHeart failure is a life threatening disease in which the heart muscle is unable to pump enough blood to meet the body\u2019s needs for blood and oxygen2<\/sup>.It affects around ~6.4 crore people worldwide (at least half of which have reduced ejection fraction), including at least 8 to 10\u00a0 million patients in India3<\/sup>. It is a chronic, degenerative\u00a0 disease where half of patients die within five years of diagnosis. Heart Failure remains as fatal as some of the most common cancers in both men (prostate and bladder cancers) and women (breast cancer) 4<\/sup>.\u00a0It is the leading cause of hospitalisation for those over the age of 65 and represents a significant clinical and economic burden5<\/sup>.\u00a0 <\/sup>Further, the mean age of\u00a0 Heart Failure is 61.2 years in Indians,\u00a0 atleast a decade\u00a0 earlier than western population.3,4,5<\/sup><\/p>\n

Gagandeep Singh, Managing Director, AstraZeneca Pharma India Limited<\/strong> said, \u201c Heart Failure is a serious health condition that affects ~6.4 crore people worldwide and at least 8\u201310 million in India. The accelerated regulatory approval in India will provide the much-needed treatment to help patients reduce their disease burden & live longer\u201d<\/p>\n

Dr. Anil Kukreja, Vice President \u2013 Medical Affairs & Regulatory, AstraZeneca India<\/strong> said, \u201cDespite currently available therapies for management of Heart failure,\u00a0 significant unmet needs exist globally as well as in India. This approval for Dapaglifozin (Forxiga) based on significant and clinically meaningful results from Dapa-HF trial provides much required confidence on a novel pharmacological approach, first in class SGLT2 inhibitor, for management of patients with HFrEF. This approval is boon for HFrEF patients in India where considerable efforts are required to address significant unmet needs of frequent hospitalization, urgent visits to hospital emergency room and cardiovascular death in HF patients despite available therapies \u201d<\/p>\n

The U.S. Food and Drug Administration approved Dapagliflozin to be used in management of patients with heart failure with reduced ejection fraction. The Canadian Cardiovascular Society has updated their guidelines\u00a0 and recommend the use of SGLT2i drugs like Dapagliflozin to manage heart failure\u00a0 to provide better patient care.<\/p>\n

Dapaglifozin (Forxiga) is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D in India. The drug is also approved for reduction of risk of hospitalisation due to Heart failure in Type 2 Diabetes patients with high risk factors.<\/p>\n

The current estimates about incidence of HF in India vary widely from 8 to 10 million\u00a0 with HFrEF being\u00a0 predominantly observed in 53% of population3,6<\/sup>. Indian patients present with HF at a younger age6<\/sup>.Prevalence of hypertension and diabetes as comorbidities are very high6<\/sup>. Hospital-stay in Indian HF patients is higher due to higher prevalence of comorbidities6<\/sup>. Prognosis of HF in Indian patients appears to be worse with In-hospital mortality of 9.7%,4<\/sup> One-year mortality of 23%8<\/sup> and 3 years the mortality of 44.8%.4<\/sup> Optimal therapy (OMT) could be initiated in less than 50% of HF patients (BB-48.8%, ACEI\/ARB-47.6%) due to multiple comorbidities in Indian patients9<\/sup>.<\/p>\n

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  1. Detailed results from Phase III DAPA-HF trial showed Farxiga significantly reduced both the incidence of cardiovascular death and the worsening of heart failure. Accessed from: https:\/\/www.astrazeneca.com\/media-centre\/press-releases\/2019\/detailed-results-from-phase-iii-dapa-hf-trial-showed-farxiga-significantly-reduced-both-the-incidence-of-cardiovascular-death-and-the-worsening-of-heart-failure-01092019.html<\/a><\/span><\/em><\/li>\n
  2. M<\/span>ayo Clinic. Heart failure; 2017 [cited 2019 Aug 14]. Available from URL: <\/span>https:\/\/www.mayoclinic.org\/diseases-conditions\/heart-failure\/symptoms-causes\/syc-20373142<\/a>.<\/span><\/em><\/li>\n
  3. Vos T et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990\u20132016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390(10100):1211\u201359.<\/span><\/em><\/li>\n
  4. Mozaffarian D et al. Circulation. 2016 Jan 26;133(4):e38-360 and the CDC: <\/span>https:\/\/www.cdc.gov\/dhdsp\/data_statistics\/fact_sheets\/fs_heart_failure.htm<\/a><\/em><\/li>\n
  5. Bhuiyan, Taslima, and Mathew S Maurer. \u201cHeart Failure with Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic Enigma.\u201d Current cardiovascular risk reports vol. 5,5 (2011): 440-449. doi:10.1007\/s12170-011-0184-2<\/span><\/em><\/li>\n
  6. Mamas, M. A., Sperrin, M., Watson, M. C., Coutts, A., Wilde, K., Burton, C., … Myint, P. K. (2017). Do patients have worse outcomes in heart failure than in cancer? A primary care-based cohort study with 10-year follow-up in Scotland. European Journal of Heart Failure, 19(9), 1095-1104.<\/span>https:\/\/doi.org\/10.1002\/ejhf.822<\/a><\/span><\/em><\/li>\n
  7. Dokainish H,\u00a0 et al. INTER-CHF Investigators. Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. Lancet Glob Health. 2017 Jul;5(7):e665-e672.<\/span><\/em><\/li>\n
  8. Sanjay G et al. In-Hospital and Three-Year Outcomes of Heart Failure Patients in South India: The Trivandrum Heart Failure Registry. J Card Fail. 2018 Dec;24(12):842-848.<\/span><\/em><\/li>\n
  9. Azad N, Lemay G.\u00a0 Management of chronic heart failure in the older population. J Geriatr Cardiol. 2014;11:329-337.<\/span><\/em><\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Dapagliflozin (Forxiga) is the first SGLT-2 inhibitor proven to significantly reduce the risk of Cardiovascular death and hospitalisation for heart failure in patients with<\/p>\n","protected":false},"author":1,"featured_media":14608,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[10,7],"tags":[19141,19146,19142,19143,19144,14096,19145],"class_list":["post-14607","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-hospital-daycare","category-lifestyle-health-hotel-leisure-food-fashion","tag-astrazeneca-pharma-india","tag-biopharmaceutical","tag-cardiovascular","tag-dapagliflozin","tag-forxiga","tag-heart-failure","tag-sglt-2-inhibitor"],"views":765,"jetpack_featured_media_url":"https:\/\/yourchennai.com\/wp-content\/uploads\/2020\/07\/Astra-Zeneca-Pharma-India-Limited-Large-3.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/posts\/14607","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/comments?post=14607"}],"version-history":[{"count":1,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/posts\/14607\/revisions"}],"predecessor-version":[{"id":14609,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/posts\/14607\/revisions\/14609"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/media\/14608"}],"wp:attachment":[{"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/media?parent=14607"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/categories?post=14607"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/yourchennai.com\/index.php\/wp-json\/wp\/v2\/tags?post=14607"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}