Diarrhoea with the angiotensin receptor neprilysin inhibitor sacubitril + valsartan: A pharmacovigilance study.
Aminobutyrates
/ adverse effects
Angiotensin Receptor Antagonists
Biphenyl Compounds
/ adverse effects
Diarrhea
/ chemically induced
Drug Combinations
Female
Humans
Male
Neprilysin
/ antagonists & inhibitors
Pharmacovigilance
Receptors, Angiotensin
Tetrazoles
/ adverse effects
Treatment Outcome
Valsartan
/ adverse effects
Entresto®
diarrhoea
drug safety
pharmacovigilance
sacubitril
valsartan
Journal
Fundamental & clinical pharmacology
ISSN: 1472-8206
Titre abrégé: Fundam Clin Pharmacol
Pays: England
ID NLM: 8710411
Informations de publication
Date de publication:
Apr 2022
Apr 2022
Historique:
revised:
17
06
2021
received:
26
05
2021
accepted:
12
07
2021
pubmed:
15
7
2021
medline:
16
3
2022
entrez:
14
7
2021
Statut:
ppublish
Résumé
Diarrhoea is an adverse drug reaction of the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril + valsartan. It was also described with olmesartan and more recently with other angiotensin receptor blockers. The study was performed to compare diarrhoea reports in pharmacovigilance databases with sacubitril + valsartan and valsartan. The study used reports of diarrhoea with the ARNI sacubitril + valsartan registered: first in the French PharmacoVigilance Database (FPVD) and second in Vigibase®, the WHO Global Individual Case Safety Report database. After description of the main characteristics, disproportionality analyses were performed. Results are reported as reporting odds ratios (ROR) with 95% confidence interval. We found 29 reports of diarrhoea with sacubitril + valsartan in the FPVD and 686 in Vigibase®. With sacubitril + valsartan, diarrhoea occurred more frequently in males around 70 years with a median delay of 3 days. With valsartan, diarrhoea occurred more frequently in females around 68 years with a median delay of 0.5 days. In the FPVD, a significant association was found with sacubitril + valsartan in comparison with valsartan alone before (ROR = 8.78 [5.19-14.85]) and after (ROR = 11.19 [5.89-21.25]) exclusion of concomitant drugs known to be associated with diarrhoea. A significant association was also found in Vigibase® after adjustment on age, sex, reporter and its location (ROR = 1.31 [1.14-1.50]). Diarrhoea reported with sacubitril + valsartan has marked differences in gender, delay of occurrence and frequency of reporting in comparison with diarrhoea with valsartan. From a pharmacodynamic point of view, these results suggest a specific role of sacubitril in diarrhoea.
Substances chimiques
Aminobutyrates
0
Angiotensin Receptor Antagonists
0
Biphenyl Compounds
0
Drug Combinations
0
Receptors, Angiotensin
0
Tetrazoles
0
sacubitril
17ERJ0MKGI
Valsartan
80M03YXJ7I
Neprilysin
EC 3.4.24.11
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
378-389Informations de copyright
© 2021 Société Française de Pharmacologie et de Thérapeutique.
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