The occurrence of drug-induced side effects in women and men with arterial hypertension and comorbidities

Abstract

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.

Keywords: comorbidities; drug-related adverse events; hypertension.