Associate Professor College of Pharmacy, Chung-Ang University, Korea, Republic of Korea
Background: Urinary dysfunction, which may lower a patient's quality of life and affects significant socioeconomic burden, may be caused by multi-comorbidities and polypharmacy.
Objectives: To identify the patterns of spontaneous reporting of urinary dysfunction associated with the increased number of suspected drugs.
Methods: We used the KIDS-KAERS database (KIDS-KD) that includes individual case safety reports (ICSRs) to the Korea Adverse Events Reporting System (KAERS) between 2016 and 2020. Cases defined as urinary dysfunction included urinary incontinence, urinary retention, micturition frequency/urgency, and nocturia using the WHO-ART code. Non-cases were defined as all reports with other adverse events (AEs), and each case was matched with 4 non-cases with age and sex. The number of drugs was defined as the sum of the number of drugs reported in each ICSR. To identify the association between polypharmacy and adverse drug reactions, reporting odds ratios (RORs) and 95% confidence intervals (CIs) were estimated by multivariate logistic regression analysis, with adjusting drug classes which have been reported as associated with urinary dysfunction: diuretics, anticholinesterases, alpha-adrenoreceptor antagonists, calcium channel blockers, analgesics, opioids, hypnotics and sedatives, antipsychotics, drugs for functional gastrointestinal disorders, adrenergics, anticholinergics, antidepressants, and angiotensin-2 receptor blockers.
Results: Among 863,042 ICSRs in the KIDS-KD, a total of 1,158 cases and 4,632 non-cases were identified after being matched. The mean (± sd) of the number of drugs included in each ICSR was 2.03 (± 1.20). In the multivariable logistic regression, 2 drugs (adjusted ROR: 0.89; 95% CI:0.72–1.10), 3 drugs (adjusted ROR: 2.47; 95% CI:1.92–3.17), and 3 or more drugs (adjusted ROR: 3.83; 95% CI:3.19–4.58) showed significantly increased ROR of urinary dysfunction, compared by ICSRs with 1 drug, when adjusting for drug classes that previously known risk for urinary dysfunction. The effect of the increasing number of drugs on the incidence of urinary dysfunction showed a similar trend in the subgroup analysis of age (in both < 65 years or ≥65 years) and gender.
Conclusions: Polypharmacy showed a significant association with spontaneous reporting of urinary dysfunction, regardless of age group or gender. Patients undergoing polypharmacy should be monitored with caution.
