Gender differences in the adverse events associated with cardiovascular drugs in a spontaneous reporting system in South Korea.

Background Studies on disease-related gender differences in pharmacodynamics and pharmacokinetics are prevalent; however, gender differences in the drug-related adverse events have not been systemically described. Objective To explore gender differences in the adverse events associated with cardiovascular drugs using a spontaneous reporting system. Setting This study was conducted using the Korea adverse event reporting system and national health insurance databases. Methods The number of reported adverse events was divided by the number of patients diagnosed with cardiovascular diseases (Korean Standard Classification of Disease, 7th Revision, I05-I70) and prescribed cardiovascular drugs. We calculated adverse event reporting rates per 100,000 persons and the reporting ratio for women, compared with men. Main outcome measures Reporting ratios across the groups of adverse events and cardiovascular drugs. Results We identified 27,533 adverse events associated with cardiovascular drugs and 9,413,666 patients with cardiovascular disease. Compared with men, reporting ratios of women were higher in the following categories: Overall (1.09, 95% CI, 1.06-1.11), beta blockers (1.20, 95% CI, 1.05-1.39), and calcium channel blockers (1.14, 95% CI, 1.03-1.27). For the adverse events, the reporting ratio was 1.34 (95% CI, 1.14-1.58) for musculoskeletal disorders and 2.54 (95% CI, 2.10-3.07) for oedema in women. Conclusion Our findings on differential adverse events reporting rates associated with the cardiovascular drugs between women and men provide an evidence on possible gender differences in wide range of pharmacotherapy. A clear understanding of the relationship between drug-induced adverse events and gender will aid in the development of therapeutic interventions being tailored to the individual patients.