Sex Differences in Reported Adverse Drug Reactions to Angiotensin-Converting Enzyme Inhibitors

Sophie H.  Bots; Michelle Schreuder; Jeanine Roeters van Lennep; Sarah  Watson; Eugene van Puijenbroek; N. Charlotte Onland-Moret; Hester M. den Ruijter

doi:10.1001/jamanetworkopen.2022.8224

Sex Differences in Reported Adverse Drug Reactions to Angiotensin-Converting Enzyme Inhibitors

Sophie H. Bots
, Michelle Schreuder
, Jeanine Roeters van Lennep
, Sarah Watson
, Eugene van Puijenbroek
, N. Charlotte Onland-Moret
, Hester M. den Ruijter^*

^*Corresponding author for this work

Internal Medicine

Utrecht University
External organisation
University of Groningen
Stichting Landelijke Registratie en Evaluatie Bijwerkingen (LAREB)
University Medical Centre Utrecht

Research output: Contribution to journal › Article › Academic › peer-review

22 Citations (Scopus)

42 Downloads (Pure)

Abstract

Sex differences in adverse drug reactions (ADRs) associated with angiotensin-converting enzyme inhibitors (ACEIs) remain poorly understood owing to a lack of sex-specific ADR data from clinical trials.1 Postmarketing pharmacovigilance data, containing structured and detailed ADR information, may play an important role in such analyses. However, these data are often not corrected for prescription numbers and therefore cannot separate sex differences in ADR risk from sex differences in prescription rates. To investigate whether women report more ACEI-related ADRs than men after correction for sex-specific prescription and describe sex differences in reported ADR types, we combined data from the global pharmacovigilance database VigiBase and the prescription-corrected Dutch pharmacovigilance database Lareb.

Original language	English
Pages (from-to)	E228224
Journal	JAMA network open
Volume	5
Issue number	4
DOIs	https://doi.org/10.1001/jamanetworkopen.2022.8224
Publication status	Published - 20 Apr 2022

Bibliographical note

Funding Information:
Funding/Support: This work was supported by grant 2020B004 from the Dutch CardioVascular Alliance and European Research Council Consolidator grant 866478.

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title = "Sex Differences in Reported Adverse Drug Reactions to Angiotensin-Converting Enzyme Inhibitors",

abstract = "Sex differences in adverse drug reactions (ADRs) associated with angiotensin-converting enzyme inhibitors (ACEIs) remain poorly understood owing to a lack of sex-specific ADR data from clinical trials.1 Postmarketing pharmacovigilance data, containing structured and detailed ADR information, may play an important role in such analyses. However, these data are often not corrected for prescription numbers and therefore cannot separate sex differences in ADR risk from sex differences in prescription rates. To investigate whether women report more ACEI-related ADRs than men after correction for sex-specific prescription and describe sex differences in reported ADR types, we combined data from the global pharmacovigilance database VigiBase and the prescription-corrected Dutch pharmacovigilance database Lareb.",

author = "Bots, \{Sophie H.\} and Michelle Schreuder and \{Roeters van Lennep\}, Jeanine and Sarah Watson and \{van Puijenbroek\}, Eugene and Onland-Moret, \{N. Charlotte\} and \{den Ruijter\}, \{Hester M.\}",

note = "Funding Information: Funding/Support: This work was supported by grant 2020B004 from the Dutch CardioVascular Alliance and European Research Council Consolidator grant 866478.",

year = "2022",

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doi = "10.1001/jamanetworkopen.2022.8224",

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AU - Bots, Sophie H.

AU - Schreuder, Michelle

AU - Roeters van Lennep, Jeanine

AU - Watson, Sarah

AU - van Puijenbroek, Eugene

AU - Onland-Moret, N. Charlotte

AU - den Ruijter, Hester M.

N1 - Funding Information: Funding/Support: This work was supported by grant 2020B004 from the Dutch CardioVascular Alliance and European Research Council Consolidator grant 866478.

PY - 2022/4/20

Y1 - 2022/4/20

N2 - Sex differences in adverse drug reactions (ADRs) associated with angiotensin-converting enzyme inhibitors (ACEIs) remain poorly understood owing to a lack of sex-specific ADR data from clinical trials.1 Postmarketing pharmacovigilance data, containing structured and detailed ADR information, may play an important role in such analyses. However, these data are often not corrected for prescription numbers and therefore cannot separate sex differences in ADR risk from sex differences in prescription rates. To investigate whether women report more ACEI-related ADRs than men after correction for sex-specific prescription and describe sex differences in reported ADR types, we combined data from the global pharmacovigilance database VigiBase and the prescription-corrected Dutch pharmacovigilance database Lareb.

AB - Sex differences in adverse drug reactions (ADRs) associated with angiotensin-converting enzyme inhibitors (ACEIs) remain poorly understood owing to a lack of sex-specific ADR data from clinical trials.1 Postmarketing pharmacovigilance data, containing structured and detailed ADR information, may play an important role in such analyses. However, these data are often not corrected for prescription numbers and therefore cannot separate sex differences in ADR risk from sex differences in prescription rates. To investigate whether women report more ACEI-related ADRs than men after correction for sex-specific prescription and describe sex differences in reported ADR types, we combined data from the global pharmacovigilance database VigiBase and the prescription-corrected Dutch pharmacovigilance database Lareb.

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Sex Differences in Reported Adverse Drug Reactions to Angiotensin-Converting Enzyme Inhibitors

Abstract

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