{"id":333077,"date":"2020-11-10T01:00:00","date_gmt":"2020-11-10T00:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/dapagliflozin-now-also-available-for-non-diabetics-for-the-treatment-of-heart-failure-hfref\/"},"modified":"2020-11-10T01:00:00","modified_gmt":"2020-11-10T00:00:00","slug":"dapagliflozin-now-also-available-for-non-diabetics-for-the-treatment-of-heart-failure-hfref","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/dapagliflozin-now-also-available-for-non-diabetics-for-the-treatment-of-heart-failure-hfref\/","title":{"rendered":"Dapagliflozin now also available for non-diabetics for the treatment of heart failure (HFrEF)"},"content":{"rendered":"

Based on the results of the DAPA-HF study, Swissmedic has approved dapagliflozin for the treatment of heart failure with reduced ejection fraction (HFrEF), whether or not patients have type 2 diabetes. The SGLT-2 inhibitor significantly reduced the risk of cardiovascular mortality and worsening heart failure in HFrEF patients as an add-on to standard therapy.<\/strong><\/p>\n

<\/p>\n

The indication extension decided by Swissmedic took place on July 2, 2020 as part of a fast track procedure. Thus, dapagliflozin (Forxiga\u00ae<\/sup>), previously used exclusively for the treatment of type 2 diabetes (T2D), has recently become the first and only SGLT-2 inhibitor*<\/sup> to be used in non-diabetics for the treatment of heart failure with reduced ejection fraction (HFrEF, NYHA class II-IV, LVEF \u226440%) [1]. Heart failure affects about 64 million people worldwide, with about half of them having reduced ejection fraction. It is a chronic and degenerative disease that causes half of patients to die within five years of diagnosis [2\u20134]. In individuals aged 65 years and older, heart failure is the leading cause of hospitalizations [5]. The indication expansion for Forxiga\u00ae<\/sup> is based on the positive results from the landmark Phase III DAPA-HF study (box) <\/strong>published in the New England Journal of Medicine.<\/p>\n

 <\/p>\n

*<\/sup> SGLT-2 inhibitor = sodium-glucose cotransporter-2 inhibitor<\/span><\/p>\n

 <\/h2>\n\n\n\n
DAPA-HF Study<\/strong>
\nDAPA-HF (Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure) is an international, multicenter, randomized, double-blind, parallel-group study in 4744 patients with heart failure and reduced ejection fraction (LVEF \u226440%, NYHA II-IV) with and without T2D to assess the effect of Forxiga\u00ae<\/sup> 10 mg (administered once daily in addition to standard therapy) compared with placebo. The primary composite end point is time to first worsening of heart failure (ie, hospitalization or a comparable event, such as an urgent visit) or cardiovascular-related death. The median observation period is 18.2 months [6].<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

 <\/h2>\n

Milestone for patients with HFrEF<\/h2>\n

Dapagliflozin (Forxiga\u00ae<\/sup>) reduced the risk of the composite endpoint of cardiovascular mortality or worsening heart failure**<\/sup> by 26% in patients HFrEF versus placebo in the DAPA-HF study as an add-on to standard therapy.
\n #<\/sup>
\n<\/span>. Over a relatively short median study duration of 18.2 months, an NNT (number needed to treat) of only 21 was achieved for the primary endpoint. Furthermore, Forxiga\u00ae<\/sup> resulted in statistically significant improvements in KCCQ***<\/sup> total symptom score at 8 months compared to placebo (+6.1 vs. +3.3 points) [6]. The KCCQ score is a patient-completed questionnaire that measures patients’ symptoms and health status and has been validated by the FDA as a reliable measure of health status in patients with heart failure [7]. The safety profile of Forxiga\u00ae<\/sup> in the DAPA-HF study was consistent with the previously reported safety profile of the drug [6]. It is important to emphasize that the rates of hypoglycemia and hypotension in the group of patients without type 2 diabetes were at placebo level [8]. With a once-daily dosage of 10 mg, without titration, Forxiga\u00ae<\/sup> offers seamless integration into any heart failure treatment regimen to optimize therapy. No change in existing heart failure medication is required [1]. Further empirical findings on the efficacy of Forxiga\u00ae<\/sup> in patients with heart failure were provided by the DECLARE cardiovascular outcomes trial, in which the SGLT-2 inhibitor, as an add-on to standard therapy, reduced the risk of the composite endpoint of hospitalization for heart failure or cardiovascular death in adults with T2D compared with placebo [9]. Based on these data, Swissmedic had decided in April 2020 to expand the indication to prevent hospitalizations for heart failure or cardiovascular death in type 2 diabetic patients [1].<\/p>\n

Source: AstraZeneca AG<\/em><\/p>\n

 <\/p>\n

** Worsening heart failure was defined as hospitalizations or emergency medical contact due to heart failure requiring subsequent intervenous therapy.<\/sup> <\/span>
\n#<\/sup> absolute risk reduction (ARR) = 4.9% (event rate\/100 patient-years: 11.6 vs. 15.6); p<0.0001<\/span>
\n***<\/span> KCCQ = Kansas City Cardiomyopathy Questionnaire<\/span><\/p>\n

 <\/p>\n

Literature:<\/p>\n

    \n
  1. Technical Information Forxiga\u00ae, www.swissmedicinfo.ch, as of July 2020.<\/li>\n
  2. Vos T et al: Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: A systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390(10100): 1211-1259.<\/li>\n
  3. Mozaffarian D, et al: Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation 2016; 133(4): e38-360.<\/li>\n
  4. Taslima B, Maurer MS: Heart Failure with Preserved Ejection Fraction: Persistent Diagnosis, Therapeutic Enigma. Current cardiovascular risk reports 2011(5): 440-449.<\/li>\n
  5. Azad N, Lemay G: Management of chronic heart failure in the elderly population. Journal of Geriatric Cardiology 2014; 11(4): 329-337.<\/li>\n
  6. McMurray JJV, et al: Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med 2019; 381(21): 1995-2008.<\/li>\n
  7. Green CP, et al: Development and Evaluation of the Kansas City Cardiomyopathy Questionnaire: A New Health Status Measure for Heart Failure. Journal of the American College of Cardiology 2000; 35(5): 1245-1255.<\/li>\n
  8. Petrie MC, et al: Effect of Dapagliflozin on Worsening Heart Failure and Cardiovascular Death in Patients With Heart Failure With and Without Diabetes. JAMA 2020; 323(14): 1353-1368.<\/li>\n
  9. Wiviott SD, et al: Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med 2019; 380(4): 347-357.<\/li>\n<\/ol>\n

     <\/p>\n

    FAMILY PRACTICE 2020; 15(8): 38<\/em>
    \nCARDIOVASC 2020; 19(3): 38<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    Based on the results of the DAPA-HF study, Swissmedic has approved dapagliflozin for the treatment of heart failure with reduced ejection fraction (HFrEF), whether or not patients have type 2…<\/p>\n","protected":false},"author":7,"featured_media":98840,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"SGLT-2 inhibitors ","footnotes":""},"category":[11359,11384,11530,11323,11548,11503],"tags":[23427,20717,12130,23432],"powerkit_post_featured":[],"class_list":["post-333077","post","type-post","status-publish","format-standard","has-post-thumbnail","category-cardiology","category-endocrinology-and-diabetology","category-market-medicine","category-partner-content-en","category-rx-en","category-studies","tag-dapagliflozin-en","tag-forxiga-en","tag-heart-failure-en","tag-sglt-2-inhibitors-en","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-09 00:34:57","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":333090,"slug":"la-dapagliflozine-desormais-disponible-pour-les-non-diabetiques-dans-le-traitement-de-linsuffisance-cardiaque-hfref","post_title":"La dapagliflozine d\u00e9sormais disponible pour les non-diab\u00e9tiques dans le traitement de l'insuffisance cardiaque (HFrEF)","href":"https:\/\/medizinonline.com\/fr\/la-dapagliflozine-desormais-disponible-pour-les-non-diabetiques-dans-le-traitement-de-linsuffisance-cardiaque-hfref\/"},"it_IT":{"locale":"it_IT","id":333102,"slug":"dapagliflozin-ora-anche-per-i-non-diabetici-per-il-trattamento-dellinsufficienza-cardiaca-hfref","post_title":"Dapagliflozin ora anche per i non diabetici per il trattamento dell'insufficienza cardiaca (HFrEF)","href":"https:\/\/medizinonline.com\/it\/dapagliflozin-ora-anche-per-i-non-diabetici-per-il-trattamento-dellinsufficienza-cardiaca-hfref\/"},"pt_PT":{"locale":"pt_PT","id":333008,"slug":"dapagliflozin-agora-tambem-para-nao-diabeticos-para-o-tratamento-da-insuficiencia-cardiaca-hfref","post_title":"Dapagliflozin agora tamb\u00e9m para n\u00e3o-diab\u00e9ticos para o tratamento da insufici\u00eancia card\u00edaca (HFrEF)","href":"https:\/\/medizinonline.com\/pt-pt\/dapagliflozin-agora-tambem-para-nao-diabeticos-para-o-tratamento-da-insuficiencia-cardiaca-hfref\/"},"es_ES":{"locale":"es_ES","id":332995,"slug":"la-dapagliflozina-ahora-tambien-para-no-diabeticos-para-el-tratamiento-de-la-insuficiencia-cardiaca-icref","post_title":"La dapagliflozina ahora tambi\u00e9n para no diab\u00e9ticos para el tratamiento de la insuficiencia cardiaca (ICrEF)","href":"https:\/\/medizinonline.com\/es\/la-dapagliflozina-ahora-tambien-para-no-diabeticos-para-el-tratamiento-de-la-insuficiencia-cardiaca-icref\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/333077","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=333077"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/333077\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/98840"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=333077"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=333077"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=333077"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=333077"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}