Sophie H Bots1, Floor Groepenhoff2, Anouk L M Eikendal1, Cara Tannenbaum3, Paula A Rochon4, Vera Regitz-Zagrosek5, Virginia M Miller6, Danielle Day7, Folkert W Asselbergs8, Hester M den Ruijter9. 1. Laboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. 2. Laboratory of Clinical Chemistry and Haematology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. 3. Faculties of Pharmacy and Medicine, Université de Montréal, Montréal, Canada. 4. Women's College Research Institute, Women's College Hospital, Toronto, Canada; Dalla Lana School of Public Health, University of Toronto, Toronto, Canada. 5. Institute for Gender in Medicine and Center for Cardiovascular Research, Charite, University Medicine Berlin, Berlin, Germany; DZHK (German Center for Cardiovascular Research), partner site Berlin, Berlin, Germany. 6. Women's Health Research Center, Mayo Clinic, Rochester, Minnesota. 7. UniQure, Amsterdam, the Netherlands. 8. Department of Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Institute of Cardiovascular Science, Faculty of Popular Health Sciences, University College London, London, United Kingdom; Health Data Research UK and Institute of Health Informatics, University College London, London, United Kingdom. 9. Laboratory of Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: h.m.denruijter-2@umcutrecht.nl.
Abstract
OBJECTIVES: This study sought to summarize all available evidence on sex differences in adverse drug reactions (ADRs) to heart failure (HF) medication. BACKGROUND: Women are more likely to experience ADRs than men, and these reactions may negatively affect women's immediate and long-term health. HF in particular is associated with increased ADR risk because of the high number of comorbidities and older age. However, little is known about ADRs in women with HF who are treated with guideline-recommended drugs. METHODS: A systematic search of PubMed and EMBASE was performed to collect all available information on ADRs to angiotensin-converting enzyme inhibitors, β-blockers, angiotensin II receptor blockers, mineralocorticoid receptor antagonists, ivabradine, and digoxin in both women and men with HF. RESULTS: The search identified 155 eligible records, of which only 11 (7%) reported ADR data for women and men separately. Sex-stratified reporting of ADRs did not increase over the last decades. Six of the 11 studies did not report sex differences. Three studies reported a higher risk of angiotensin-converting enzyme inhibitor-related ADRs in women, 1 study showed higher digoxin-related mortality risk for women, and 1 study reported a higher risk of mineralocorticoid receptor antagonist-related ADRs in men. No sex differences in ADRs were reported for angiotensin II receptor blockers and β-blockers. Sex-stratified data were not available for ivabradine. CONCLUSIONS: These results underline the scarcity of ADR data stratified by sex. The study investigators call for a change in standard scientific practice toward reporting of ADR data for women and men separately.
OBJECTIVES: This study sought to summarize all available evidence on sex differences in adverse drug reactions (ADRs) to heart failure (HF) medication. BACKGROUND:Women are more likely to experience ADRs than men, and these reactions may negatively affect women's immediate and long-term health. HF in particular is associated with increased ADR risk because of the high number of comorbidities and older age. However, little is known about ADRs in women with HF who are treated with guideline-recommended drugs. METHODS: A systematic search of PubMed and EMBASE was performed to collect all available information on ADRs to angiotensin-converting enzyme inhibitors, β-blockers, angiotensin II receptor blockers, mineralocorticoid receptor antagonists, ivabradine, and digoxin in both women and men with HF. RESULTS: The search identified 155 eligible records, of which only 11 (7%) reported ADR data for women and men separately. Sex-stratified reporting of ADRs did not increase over the last decades. Six of the 11 studies did not report sex differences. Three studies reported a higher risk of angiotensin-converting enzyme inhibitor-related ADRs in women, 1 study showed higher digoxin-related mortality risk for women, and 1 study reported a higher risk of mineralocorticoid receptor antagonist-related ADRs in men. No sex differences in ADRs were reported for angiotensin II receptor blockers and β-blockers. Sex-stratified data were not available for ivabradine. CONCLUSIONS: These results underline the scarcity of ADR data stratified by sex. The study investigators call for a change in standard scientific practice toward reporting of ADR data for women and men separately.
Authors: Floor Groepenhoff; Sophie H Bots; Elise L Kessler; Ariane A Sickinghe; Anouk L M Eikendal; Tim Leiner; Hester M den Ruijter Journal: J Cardiovasc Transl Res Date: 2019-08-30 Impact factor: 4.132
Authors: Anyuli Gracia Gutiérrez; Beatriz Poblador-Plou; Alexandra Prados-Torres; Fernando J Ruiz Laiglesia; Antonio Gimeno-Miguel Journal: Int J Environ Res Public Health Date: 2020-03-23 Impact factor: 3.390