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European Journal of Clinical Pharmacology

, Volume 74, Issue 7, pp 983–984 | Cite as

Serious adverse drug reactions with sacubitril/valsartan Entresto®: a French pharmacovigilance survey

  • Florence Moulis
  • Vanessa Rousseau
  • Leila Chebane
  • Amandine Gouverneur
  • Louise Gaboriau
  • Jean-Luc Faillie
  • Geneviève Durrieu
  • François Montastruc
  • Jean-Louis Montastruc
Letter to the Editor
First Online:
Received:
Accepted:

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 [1]. 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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Notes

Compliance with ethical standards

Conflicts of interest

The authors declare that they have no conflict of interest.

Disclaimer

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.

References

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    McMurray JJV, PackeR M, DesaI AS, Jianjian Gong J, Lefkowitz MP, Rizkala AR, Rouleau JL, Shi VC, Solomon SD, Swedberg K, Zile MR, For the PARADIGM-HF investigators and committees (2014) Angiotensin–neprilysin inhibition versus enalapril in heart failure. N Engl J Med 371:993–1004CrossRefPubMedGoogle Scholar
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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2018

Authors and Affiliations

  • Florence Moulis
    • 1
  • Vanessa Rousseau
    • 1
  • Leila Chebane
    • 1
  • Amandine Gouverneur
    • 2
  • Louise Gaboriau
    • 3
  • Jean-Luc Faillie
    • 4
    • 5
  • Geneviève Durrieu
    • 1
  • François Montastruc
    • 1
  • Jean-Louis Montastruc
    • 1
  1. 1.Service de Pharmacologie Médicale et Clinique, Centre de Pharmacovigilance, de Pharmacoépidémiologie et d’Informations sur le Médicament, CIC 1436, INSERM UMR 1027, Faculté de MédecineCentre Hospitalier UniversitaireToulouseFrance
  2. 2.Service de Pharmacologie Médicale, Centre de PharmacoVigilance, Centre Hospitalier Universitaire, Pôle de Santé Publique, Inserm Bordeaux Population Health Research Center, Team Pharmacoepidemiology, UMR 1219University of BordeauxBordeauxFrance
  3. 3.Centre de PharmacoVigilance du Nord Pas-de-Calais, CHRULille cedexFrance
  4. 4.Centre Régional de PharmacoVigilance, CHU MontpellierMontpellierFrance
  5. 5.Laboratoire de Biostatistique, Epidémiologie et Santé Publique, EA 2415Université de MontpellierMontpellierFrance

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