Key result
Women with arterial hypertension reported adverse drug reactions significantly more frequently than men (52.1% vs. 40.5%), with risk factors differing by sex.
Why the study?
Women have been underrepresented in large hypertension trials, and the incidence of adverse drug reactions by sex has not been sufficiently described.
What is the prevalence and what are the predisposing factors for adverse drug reactions in women versus men with arterial hypertension and comorbidities?
Observational (n=1,000)
No
What is the prevalence and what are the predisposing factors for adverse drug reactions in women versus men with arterial hypertension and comorbidities?
Absolute Event Rate: 52.1% vs 40.5%
p-value: p=<0.001
Women with arterial hypertension experience significantly more adverse drug reactions than men, highlighting the need for sex-specific monitoring and personalized pharmacotherapy.
Women with hypertension may need closer ADR monitoring; this Level 5 analysis leaves open whether sex-specific factors should inform personalized regimens.
BACKGROUND: Women have been underrepresented in large clinical trials in hypertension, and the incidence of adverse drug reactions by sex has been not sufficiently described. AIMS: The aim of the study was to determine the prevalence of adverse drug reactions in women and men with arterial hypertension and comorbidities and to assess the specific predisposing factors for adverse drug reactions by sex. METHODS: The study population comprised consecutive hospitalized patients diagnosed with arterial hypertension and patients treated in an outpatient clinic, whose recruitment started in January 2019 aiming to reach 1000 participants. A structured questionnaire was used to gather the patients' demographic and clinical data and current or past cases of adverse drug reactions. RESULTS: The study included 560 women and 440 men, with mean (standard deviation) age of 62.84 (14.96) years. Women were older than men, had a longer hypertension history, and suffered less frequently from other cardiovascular diseases. Women reported more frequently adverse drug reactions. The risk of drug-induced side effects in women increased with age (P = 0.03) and with coexistence of any respiratory disease (P = 0.04). In the case of male sex, the risk of adverse drug reactions increased with the occurrence of hypercholesterolemia (P = 0.03), and coexistence of any analyzed metabolic diseases (P = 0.04). CONCLUSIONS: Adverse drug reactions were reported more frequently by women. Older age and the presence of any respiratory disease increased the risk of adverse drug reactions in women, while in men, the risk was increased mainly by the presence of hypercholesterolemia or other metabolic diseases.
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Polaczyk et al. (2022) conducted an observational in Arterial hypertension and comorbidities (n=1,000). Female sex vs. Male sex was evaluated on Occurrence of adverse drug reactions (p=<0.001). Women with arterial hypertension reported adverse drug reactions significantly more frequently than men (52.1% vs. 40.5%), with risk factors differing by sex.
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