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Eur J Clin Pharmacol. 2018 Sep;74(9):1165-1173. doi: 10.1007/s00228-018-2480-y. Epub 2018 May 27.

Sex differences in spontaneous reports on adverse drug events for common antihypertensive drugs.

Author information

1
Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden. diana.rydberg@ki.se.
2
Clinical Pharmacology, Drug Evaluation Unit, L7:03, Karolinska University Hospital Solna, 17176, Stockholm, Sweden. diana.rydberg@ki.se.
3
Clinical Pharmacology, Drug Evaluation Unit, L7:03, Karolinska University Hospital Solna, 17176, Stockholm, Sweden.
4
Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.
5
Public Healthcare Services Committee, Stockholm County Council, Stockholm, Sweden.
6
Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.

Abstract

PURPOSE:

To explore sex differences in spontaneously reported adverse drug events (ADEs) for antihypertensives in routine care.

METHODS:

A cross sectional analysis combining number of reports from the national pharmacovigilance database with data from the Swedish Prescribed Drug Register, from 2005 to 2012 for ACE inhibitors (ACE-I) and angiotensin receptor blockers (ARB), with or without thiazide, diuretics (thiazides, potassium-sparing agents, sulfonamides, aldosterone antagonists), selective betablockers, and dihydropyridine calcium-channel-blockers (DHPs). The total number of reports was adjusted to exposed patients and dispensed DDDs among women and men. Dose exposures, co-medications, and co-prescriptions were also analyzed.

RESULTS:

In women, a higher prevalence of ADE-reports was seen in ACE-I (odds ratio, OR 1.21; 95% CI 1.09-1.35), ACE-I-combinations (OR 1.61; 1.44-1.79), ARB-combinations (OR 2.12; 1.47-3.06), thiazides (OR 1.78; 1.33-2.39), diuretics and potassium-sparing agents (OR 1.62; 1.22-2.17), and DHPs (OR 1.40; 1.17-1.67), with a potential linkage to dose exposure. For aldosterone antagonists, we observed a higher prevalence of ADE reports in men (OR 0.75; 0.59-0.97) but without any sex difference in dose exposure.

CONCLUSIONS:

This ecological study of reported ADEs showed a higher prevalence of reports in women in six out of ten groups of antihypertensive drugs, and this may potentially be linked to dose exposure. Aldosterone antagonists was the only group with a higher prevalence of ADE-reports in men with a similar dose exposure between women and men.

KEYWORDS:

Adverse drug events; Antihypertensive treatment; Men; Sex-differences; Women

PMID:
29804162
PMCID:
PMC6096710
DOI:
10.1007/s00228-018-2480-y
[Indexed for MEDLINE]
Free PMC Article

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