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

Autor: Karin Schenck-Gustafsson, Diana M. Rydberg, Rickard E. Malmström, Desirée Loikas, Mia von Euler, Stefan Mejyr
Rok vydání: 2018
Předmět:
Male
Drug
medicine.medical_specialty
Databases
Factual
Drug-Related Side Effects and Adverse Reactions
Pharmacoepidemiology and Prescription
Cross-sectional study
media_common.quotation_subject
DHPS
030204 cardiovascular system & hematology
Adverse drug events
Pharmacovigilance
03 medical and health sciences
chemistry.chemical_compound
Sex Factors
0302 clinical medicine
Risk Factors
Antihypertensive treatment
Internal medicine
Prevalence
medicine
Adverse Drug Reaction Reporting Systems
Humans
Women
Pharmacology (medical)
030212 general & internal medicine
Antihypertensive Agents
Thiazide
media_common
Sweden
Pharmacology
Aldosterone
Dose-Response Relationship
Drug
business.industry
Ecological study
Men
General Medicine
Odds ratio
Sex-differences
Cross-Sectional Studies
chemistry
Female
business
medicine.drug
Zdroj: European Journal of Clinical Pharmacology
ISSN: 1432-1041
0031-6970
Popis: 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. Electronic supplementary material The online version of this article (10.1007/s00228-018-2480-y) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
Externí odkaz: