{"id":"b38c99055351","type":"article","url":"https://hartvaat.nl/2021/12/01/sacubitril-valsartan-uitgebreide-fda-labeling-jama-cardiology-implicaties/","title":"Sacubitril/valsartan uitgebreide FDA-labeling: JAMA Cardiology implicaties","title_en":"Potential Implications of Expanded US Food and Drug Administration Labeling for Sacubitril/Valsartan in the US.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":[],"journal":"JAMA cardiology","doi":"10.1001/jamacardio.2021.3651","source_url":"https://doi.org/10.1001/jamacardio.2021.3651","authors":["Muthiah Vaduganathan","Brian L Claggett","Stephen J Greene","Rahul Aggarwal","Ankeet S Bhatt","John J V McMurray","Gregg C Fonarow","Scott D Solomon"],"significance":6,"published":"2021-12-01","source_date":"2021-12-01","image":"","kennis":[],"congress":"","summary_en":"This analysis estimated the potential impact of expanded FDA labeling for sacubitril-valsartan (including HF with LVEF above 40%) on the eligible US patient population, quantifying the implementation opportunity.","created":"2026-07-03T10:29:32Z","updated":"2026-07-03T13:28:40Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"JAMA Cardiology analyse naar de potentiële implicaties van uitgebreide FDA-labeling voor sacubitril/valsartan.","abstract_original":"IMPORTANCE: The US Food and Drug Administration (FDA) expanded labeling for sacubitril/valsartan for use in individuals with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) lower than normal. The population-level implications of implementation of sacubitril/valsartan at higher LVEF ranges is unknown. While the Prospective Comparison of ARNI With ARB Global Outcomes in HF With Preserved Ejection Fraction (PARAGON-HF) trial did not meet its primary end point, the trial may provide useful information in projecting expected clinical events among treated individuals. OBJECTIVE: To quantify newly eligible treatment candidates for sacubitril/valsartan under the expanded FDA labeling and to apply treatment effects and the number needed to treat (NNT) to prevent 1 worsening HF event derived from subgroups of the PARAGON-HF trial who fall under the revised FDA label. DESIGN, SETTING, AND PARTICIPANTS: Newly eligible treatment candidates were estimated by mapping the LVEF distribution from 559 520 adult patients hospitalized between 2014 and 2019 in the Get With The Guidelines-Heart Failure registry to adults self-identifying with HF in the National Health and Nutrition Examination Survey (2015 to 2018). The NNT with 3 years of treatment for 3 end points of interest (total HF hospitalizations, total HF hospitalizations and cardiovascular death, and total HF hospitalizations and urgent HF visits and cardiovascular death) were estimated from the PARAGON-HF trial. Data were analyzed from February to June 2021. MAIN OUTCOMES AND MEASURES: Number of worsening HF events prevented or postponed if eligible patients were treated with sacubitril/valsartan for 3 years. RESULTS: Of an estimated 4 682 098 adults, the mean (SE) age was 66.3 (0.8) years, 1 995 037 (42.6%) were women, and 748 045 (16.0%) were Black. The potential number of adults projected to be newly eligible varied by the definition of FDA labeling of lower than normal LVEF from 643 161 (95% CI, 534 433-751 888; LVEF of 41% to 50%) to 1 838 756 (95% CI, 1 527 911-2 149 601; LVEF of 41% to 60%). In the PARAGON-HF trial, the NNT to prevent a worsening HF event (range, 7 to 12 patients) was consistent irrespective of specific LVEF range selected. Comprehensive implementation of sacubitril/valsartan among newly eligible patients was empirically estimated to prevent up to 69 268 (95% CI, 57 558-80 978) worsening HF events (LVEF of 41% to 50%) to 182 592 (95% CI, 151 725-213 460) worsening HF events (LVEF of 41% to 60%). CONCLUSIONS AND RELEVANCE: The expanded FDA labeling is positioned to substantially increase the potential HF population eligible for sacubitril/valsartan by up to 1.8 million individuals and has the potential to prevent or postpone as many as 180 000 worsening HF events, depending on the definition of normal LVEF."}