CARDIOVASCULAR JOURNAL OF AFRICA • Volume 33, No 5, September/October 2022 286 AFRICA FDA approves empagliflozin for heart failure regardless of ejection fraction The US Food & Drug Administration (FDA) has announced that empagliflozin (Jardiance) may now be marketed for heart-failure patients, regardless of their ejection fraction. The agency granted approval to Boehringer Ingelheim’s SGLT2 inhibitor for the indication of reducing the risk of cardiovascular death and hospitalisation in adults with heart failure, reports MedPage Today. This new indication makes empagliflozin the only cardiovascular disease-prevention medication on the market with a proven track record for people with heart failure with preserved ejection fraction (HFpEF), a group that has been notoriously hard to treat. In February 2021, sacubitril/valsartan (Entresto) became the first drug approved for prevention of cardiovascular death and hospitalisation in some HFpEF patients. However, that approval came despite the drug failing to significantly reduce heart-failure hospitalisation and cardiovascular death in this group, compared with valsartan alone in the PARAGON-HF trial. ‘Today’s approval will provide a treatment option for a wider range of patients with heart failure,’ said Dr Norman Stockbridge, of the FDA’s Center for Drug Evaluation and Research, in a press release announcing empagliflozin’s approval. ‘While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure. Coinciding with February’s annual observance of American Heart Month – a reminder for individuals to focus on cardiovascular health – this action will provide physicians with another tool to address heart disease,’ he said. FDA approved empagliflozin’s new broader heart-failure indication on the basis of EMPEROR-Preserved, which was reported last August at the European Society of Cardiology annual meeting. In nearly 6 000 people with ejection fraction greater than 40%, empagliflozin 10 mg once daily reduced a composite endpoint of cardiovascular death and heart-failure hospitalisation by more than 20%, relative to placebo over approximately two years, with these results mainly driven by the difference in heart-failure hospitalisations. Empagliflozin was first approved in 2014 to lower blood sugar (when used with diet and exercise) in adults with type 2 diabetes. Over the years, it also accumulated the indications for reducing risk of cardiovascular death in people with type 2 diabetes and established cardiovascular disease, as well as preventing deaths and hospitalisations in people with heart failure and reduced ejection fraction. Potential side effects of the SGLT2 inhibitor include ketoacidosis, dehydration, serious urinary tract infections and low blood sugar. MedicalBrief 2022 Past, the Present and the Future. Adelaide: The University of Adelaide Press, 2018: 1–8. 8. Wong LCH, Behr ER. Sudden unexplained death in infants and children: The role of undiagnosed inherited cardiac conditions. Europace 2014; 16: 1706–1713. 9. Campuzano O, Fernandez-Falgueras A, Sarquella-Brugada G, et al. Personalized interpretation and clinical translation of genetic variants associated with cardiomyopathies. Front Genet 2019; 10: 450. 10. Ahmad F, McNally EM, Ackerman MJ, et al.; on behalf of the American Heart Association Council on Genomic and Precision Medicine; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Basic Cardiovascular Sciences; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology; and Stroke Council. Establishment of specialized clinical cardiovascular genetics programs: recognizing the need and meeting standards: a scientific statement from the American Heart Association. Circ Genom Precis Med 2019; 12: e000054. 11. Children’s Cardiomyopathy Foundation. Dilated cardiomyopathy. New Jersey: Children’s Cardiomyopathy Foundation; [updated 2020/05; cited 2020/05/22]. Available from: http://dev.childrenscardiomyopathy.org/ dcm-22-25. 12. Shaboodien G, Spracklen TF, Kamuli S, et al. Genetics of inherited cardiomyopathies in Africa. Cardiovasc Diagn Ther 2019; 10: 262–278. 13. Millat G, Chevalier P, Restier-Milon L, et al. Spectrum of pathogenic mutations and associated polymorphisms in a cohort of 44 unrelated patients with long QT syndrome. Clin Genet 2006; 70: 214–227. 14. Wang D, Shah KR, Yon Um S, et al. Cardiac channelopathy testing in 274 ethnically diverse sudden unexplained deaths. Forensic Sci Int 2014; 237: 90–99. 15. McNair WP, Ku L, Taylor MRG, et al. SCN5A mutation associated with dilated cardiomyopathy, conduction disorder, and arrhythmia. Circulation 2004; 110: 2163–2167. 16. Shi R, Zhang Y, Yang C, et al. The cardiac sodium channel mutation delQKP 1507–1509 is associated with the expanding phenotypic spectrum of LQT3, conduction disorder, dilated cardiomyopathy, and high incidence of youth sudden death. Europace 2008; 10: 1329–1335. 17. Online Mendelian Inheritance in Man. 600163 – Sodium channel, voltage-gated, type v, alpha subunit; SCN5A. Maryland, USA: Johns Hopkins University [updated 2020/03; cited 2020/03/25]. Available from: www.omim.org/entry/600163. 18. GenAtlas. Genes – SCN5A. Paris: Paris Descartes University [updates 2020/03; cited 2020/03/24]. Available from: www.genatlas.medicine.univparis5.fr/fiche.php?symbol=SCN5A. 19. P´erez-Serra A, Toro R, Sarquella-Brugada G, et al. Genetic basis of dilated cardiomyopathy. Int J Cardiol 2016; 224: 461–472. 20. Phoon CKI, Halvorsen M, Goldstein DB, et al. Sudden unexpected death in asymptomatic infants due to PPA2 variants. Mol Genet Genom Med 2019; 8: e1008. 21. Lipshultz SE, Law YM, Asante-Korang A, et al.; on behalf of the American Heart Association Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Council on Genomic and Precision Medicine. Cardiomyopathy in children: classification and diagnosis: a scientific statement from the American Heart Association. Circulation 2019; 140: e9–e68. 22. Suarez ES, Knollmann-Ritschel, BEC. Educational case: Genetic mutations and multifactorial inheritance: dilated cardiomyopathy. Acad Pathol 2017; 4: 1–3. 23. Lee TM, Hsu DT, Kantor P, et al. Pediatric cardiomyopathies. Circ Res 2017; 121: 855–873. 24. Ferrante L, Opdal SH, Nygård S, et al. Gene expression profile in cases of infectious death in infancy. Pediatr Res 2021; 89: 483–487.
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