Serious adverse drug reactions with sacubitril/valsartan Entresto®: a French pharmacovigilance survey
Entresto® is a combination of sacubitril, a prodrug whose metabolite inhibits neprilysin (which degrades natriuretic peptides), plus valsartan, an angiotensin receptor antagonist. Sacubitril/valsartan (SV) induces vasodilation, diuresis, and natriuresis increases glomerular filtration rate and renal blood flow. The pivotal clinical trial (PARADIGM-HF) in chronic heart failure (HF) showed a significant 20% decrease in the primary composite outcome (cardiovascular death or hospitalization) with SV versus enalapril alone . Since clinical trials cannot fully evaluate the risk profile of drugs, the present work was performed to describe adverse drug reactions (ADRs) associated with the use of SV in real life in France.
We performed a retrospective analysis of ADRs reported to the French pharmacovigilance network and registered in the French PharmacoVigilance Database (FPVD) from 7th January 2016 (first day of SV’s marketing in France) to 31st May 2017. The FPVD was built in 1985 to...
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Conflicts of interest
The authors declare that they have no conflict of interest.
The content of this article only involved the authors and the opinions and conclusions are not necessary those of ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé). Authors of this article are solely responsible for the conclusions.
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