{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T14:52:45Z","timestamp":1788447165034,"version":"build-2803163510"},"reference-count":26,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,9,5]],"date-time":"2017-09-05T00:00:00Z","timestamp":1504569600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Fundamemntal Clinical Pharma"],"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The purpose of this study was to assess the impact of age and sex on the reporting of cough and angioedema related to renin\u2013angiotensin system (<jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content>) inhibitors. A case\/noncase study was performed in VigiBase. Two case groups were identified, reports of cough and reports of angioedema, and noncases were all reports of all other adverse events. Logistic regression analysis was used to assess the association between reporting of cough and angioedema with each class of <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content> inhibitors stratified by age\/sex and to control for confounding. The reporting of cough with angiotensin\u2010converting enzyme (<jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content>) inhibitors was significantly higher in women than in men [adjusted reporting odds ratio (<jats:styled-content style=\"fixed-case\">ROR<\/jats:styled-content>): 44.0, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> (43.2\u201344.8) for women vs. 29.2, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> (28.5\u201329.9) for men]. There was no difference in reporting of cough linked to angiotensin receptor blockers (<jats:styled-content style=\"fixed-case\">ARB<\/jats:styled-content>s) and aliskiren between men and women. In contrast, the reporting of angioedema with <jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content> inhibitors and <jats:styled-content style=\"fixed-case\">ARB<\/jats:styled-content>s was significantly higher in men than in women, but for aliskiren, women had a significantly higher <jats:styled-content style=\"fixed-case\">ROR<\/jats:styled-content> than men [adjusted <jats:styled-content style=\"fixed-case\">ROR<\/jats:styled-content>: 5.20, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> (4.18\u20136.46) for women vs. 3.04, 95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> (2.30\u20134.02) for men]. The reporting of cough with <jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content> inhibitors was increased with age until reaching a plateau at middle adulthood (40\u201359\u00a0years) and the reporting of angioedema with <jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content> inhibitors was increased with age until elderly (60\u201379\u00a0years). Age had only a slight effect on the reporting of cough and angioedema with <jats:styled-content style=\"fixed-case\">ARB<\/jats:styled-content>s and aliskiren. Both age and sex have substantial effects on the reporting of cough and angioedema with <jats:styled-content style=\"fixed-case\">RAS<\/jats:styled-content> inhibitors and in particular <jats:styled-content style=\"fixed-case\">ACE<\/jats:styled-content> inhibitors. Further study is needed to determine whether these differences mainly express different adverse drug reaction risks in subgroups or also can be explained by factors influencing reporting.<\/jats:p>","DOI":"10.1111\/fcp.12313","type":"journal-article","created":{"date-parts":[[2017,8,2]],"date-time":"2017-08-02T15:46:38Z","timestamp":1501688798000},"page":"676-684","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":28,"title":["The impact of age and sex on the reporting of cough and angioedema with renin\u2013angiotensin system inhibitors: a case\/noncase study in VigiBase"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4014-1962","authenticated-orcid":false,"given":"Fawaz F.","family":"Alharbi","sequence":"first","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anzhelika A.V.","family":"Kholod","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick C.","family":"Souverein","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronald H.","family":"Meyboom","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark C.H.","family":"de Groot","sequence":"additional","affiliation":[{"name":"Division of Laboratory and Pharmacy Department of Clinical Chemistry and Haematology University Medical Center Utrecht PO Box 85500 3508 GA Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthonius","family":"de Boer","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olaf H.","family":"Klungel","sequence":"additional","affiliation":[{"name":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences Utrecht University PO Box\u00a080 082 3508 TB Utrecht The Netherlands"},{"name":"Julius Center for Health Sciences and Primary Care University Medical Center Utrecht PO Box 85500 3508 GA Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2017,9,5]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-011-1938-8"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1517\/14740338.5.5.631"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1161\/01.CIR.0000153269.07762.3B"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjcard.2012.03.034"},{"issue":"12","key":"e_1_2_8_6_1","first-page":"CD004136","article-title":"Antihypertensive agents for preventing diabetic kidney disease","author":"Lv J.","year":"2012","journal-title":"Cochrane Database Syst. 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