publication . Article . Other literature type . 2016

Reconciling Disparities Between Preclinical and Clinical Investigations

Feldman, Arthur M.; Haller, Julia A.; DeKosky, Steven T.;
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  • Published: 05 Jan 2016 Journal: JAMA, volume 315, page 25 (issn: 0098-7484, Copyright policy)
  • Publisher: American Medical Association (AMA)
Abstract
Valsartan/sacubitril (Entresto, Novartis) is a combination of the neprilysin inhibitor sacubitril and the angiotensin receptor antagonist valsartan. In July 2015, the US Food and Drug Administration (FDA) approved valsartan/sacubitril through the fast-track pathway for the treatment of patients with New York Heart Association class II through IV heart failure symptoms and a reduced ejection fraction. The approval was based on the results of a single phase 3 clinical trial (PARADIGM-HF)1 that included 8400 patients. In this trial, valsartan/sacubitril was associated with a 20% (hazard ratio, 0.80) decrease in the primary end point of death from cardiovascular cau...
Subjects
free text keywords: Ejection fraction, Cardiology, medicine.medical_specialty, medicine, Valsartan, medicine.drug, Heart failure, medicine.disease, Hazard ratio, Enalapril, Clinical endpoint, Sacubitril, Valsartan, business.industry, business, Internal medicine, Sacubitril
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