{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,24]],"date-time":"2026-03-24T10:27:39Z","timestamp":1774348059000,"version":"3.50.1"},"reference-count":28,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T00:00:00Z","timestamp":1627516800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,7,29]],"date-time":"2021-07-29T00:00:00Z","timestamp":1627516800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2022,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Diarrhoea is an adverse drug reaction of the angiotensin receptor neprilysin inhibitor (ARNI) sacubitril\u2009+\u2009valsartan. 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\u2009+\u2009valsartan and valsartan. The study used reports of diarrhoea with the ARNI sacubitril\u2009+\u2009valsartan registered: first in the French PharmacoVigilance Database (FPVD) and second in Vigibase\u00ae, 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\u2009+\u2009valsartan in the FPVD and 686 in Vigibase\u00ae. With sacubitril\u2009+\u2009valsartan, diarrhoea occurred more frequently in males around 70\u2009years with a median delay of 3\u2009days. With valsartan, diarrhoea occurred more frequently in females around 68\u2009years with a median delay of 0.5\u00a0days. In the FPVD, a significant association was found with sacubitril\u2009+\u2009valsartan in comparison with valsartan alone before (ROR\u2009=\u20098.78 [5.19\u201314.85]) and after (ROR\u2009=\u200911.19 [5.89\u201321.25]) exclusion of concomitant drugs known to be associated with diarrhoea. A significant association was also found in Vigibase\u00ae after adjustment on age, sex, reporter and its location (ROR\u2009=\u20091.31 [1.14\u20131.50]). Diarrhoea reported with sacubitril\u2009+\u2009valsartan 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.<\/jats:p>","DOI":"10.1111\/fcp.12717","type":"journal-article","created":{"date-parts":[[2021,7,14]],"date-time":"2021-07-14T12:50:32Z","timestamp":1626267032000},"page":"378-389","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Diarrhoea with the angiotensin receptor neprilysin inhibitor sacubitril\u2009+\u2009valsartan: A pharmacovigilance study"],"prefix":"10.1111","volume":"36","author":[{"given":"Julia","family":"Guion\u2010Firmin","sequence":"first","affiliation":[{"name":"Service de Pharmacologie M\u00e9dicale et Clinique, Centre de Pharmacovigilance de Pharmaco\u00e9pidemiologie et d'Informations sur le M\u00e9dicament, CIC INSERM 1436 Centre Hospitalier Universitaire\u2010Facult\u00e9 de M\u00e9decine  Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Samuel","family":"Tessier","sequence":"additional","affiliation":[{"name":"Service de Pharmacologie M\u00e9dicale et Clinique, Centre de Pharmacovigilance de Pharmaco\u00e9pidemiologie et d'Informations sur le M\u00e9dicament, CIC INSERM 1436 Centre Hospitalier Universitaire\u2010Facult\u00e9 de M\u00e9decine  Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marion","family":"Lepelley","sequence":"additional","affiliation":[{"name":"Centre de Pharmacovigilance, Centre Hospitalier Universitaire Universit\u00e9 de Grenoble  Grenoble France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean\u2010Luc","family":"Faillie","sequence":"additional","affiliation":[{"name":"Centre de Pharmacovigilance, Centre Hospitalier Universitaire Universit\u00e9 de Montpellier  Montpellier France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6341-6001","authenticated-orcid":false,"given":"Jean\u2010Louis","family":"Montastruc","sequence":"additional","affiliation":[{"name":"Service de Pharmacologie M\u00e9dicale et Clinique, Centre de Pharmacovigilance de Pharmaco\u00e9pidemiologie et d'Informations sur le M\u00e9dicament, CIC INSERM 1436 Centre Hospitalier Universitaire\u2010Facult\u00e9 de M\u00e9decine  Toulouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,7,29]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehw128"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1409077"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-018-2460-2"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.mayocp.2012.06.003"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0125024"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.humpath.2015.12.001"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11894-019-0726-1"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2020.02.023"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12850"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.14309\/crj.2015.15"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/MCG.0000000000000383"},{"key":"e_1_2_9_13_1","first-page":"62","article-title":"Angiotensin II receptor blockers\u2010induced enteropathy: not just olmesartan! A Case Report with Candesartan","volume":"30","author":"Mondet L","year":"2016","journal-title":"Fund Clin Pharmacol"},{"issue":"2","key":"e_1_2_9_14_1","first-page":"87","article-title":"Celiac disease\u2010like enteropathy due to antihypertensive therapy with the angiotensin\u2010II receptor type 1 inhibitor eprosartan","volume":"51","author":"Maier H","year":"2015","journal-title":"Cesk Patol"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/009286150804200501"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2020.02.022"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2019.09.004"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)02799-9"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.therap.2019.01.006"},{"key":"e_1_2_9_20_1","unstructured":"Committee for Medicinal Products for Human Use (CHMP). 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