(180) Sex Differences in The Number and Type of Adverse Drug Reactions Reported for Common Cardiovascular Medications in a Cardiac Outpatient Population

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 511

Presenting Author(s)

Sophie H. Bots, PhD
– Assistant Professor, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands, Utrecht University, Utrecht, Utrecht, Netherlands

Co-Author(s)

Milena Jancev
– Laboratory for Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands, Netherlands
N. Charlotte Onland-Moret
– Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands, Netherlands
Igor I. Tulevski
– Cardiology Centers of the Netherlands, Amsterdam, The Netherlands, Netherlands
G. Aernout Somsen
– Cardiology Centers of the Netherlands, Amsterdam, The Netherlands, Netherlands
Hester M. den Ruijter
– Laboratory for Experimental Cardiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands, Netherlands

Background: Literature suggests women report more adverse drug reactions (ADRs) for cardiovascular (CV) medication than men, but most studies were unable to correct for prescription rates. It therefore remains unclear whether women report more ADRs because they experience them more often or because prescription rates are higher in women.

Objectives: To determine whether women treated with common CV medications report more ADRs than men after correction for sex-specific prescription rates.

Methods: The Cardiology Centers of the Netherlands database comprises women and men referred for cardiac workup between 2007 and 2018 by their general practitioner on suspicion of cardiac disease. We analysed CV medications with over 10,000 prescriptions: angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, aspirin, beta-blockers, calcium channel blockers (CCBs), nitrates, statins, and thiazide diuretics. ADRs were defined as the recorded reasons for discontinuing a prescription. The number of ADRs was corrected for total number of prescriptions per medication group and sex. The χ2 test was used to test whether women reported more ADRs than men. We also calculated sex differences in ADR type according to the MedDRA system organ classes.

Results: We analysed 63,898 patients (50% women) who received 212,618 prescriptions (48% from women). Women had fewer prescriptions overall (2 [1-4] vs 3 [2-5], p< 0.001), but more discontinued prescriptions due to ADRs than men (3516 vs 3260, p< 0.001). They also stopped their prescription earlier than men in case of an ADR (65 days [21-266] vs 105 days [32-371]). After correction for total number of prescriptions, women had more ADR-related discontinued prescriptions than men for all medication classes. The largest difference was seen for CCBs (565 vs 376 ADRs per 10.000 prescriptions, p < 0.001). Nervous system, immune system, and gastrointestinal system disorders were more often reported by women across medication classes, compared with cardiac and renal and urinary disorders for men.

Conclusions: Women more often discontinue their CV medication prescription because of ADRs and do so earlier than men. Women and men reported different ADRs for the same medication groups. These sex differences need to be considered in both prescription and monitoring of cardiovascular medications.