Metoprolol dominated beta-blocker prescriptions in China at 62.2%, while safety analysis identified new adverse reaction signals including BRASH syndrome for metoprolol (ROR 391.285).
Observational (n=5,928,173)
Yes
What are the prescribing patterns of beta-blockers in China and what are their associated adverse event risk signals in the FAERS database?
Metoprolol is the most commonly prescribed beta-blocker in China, but clinicians should be aware of widespread off-label use and newly identified safety signals such as BRASH syndrome.
BACKGROUND: Beta-blockers are widely used, with continuously updated clinical recommendations. However, their application faces challenges in personalized treatment and safety. The study aimed to investigate the frequency and patterns of prescribing beta-blockers in China and to explore potential adverse event risk signals associated with beta-blockers, providing reference for rational medication use in clinical settings. METHODS: Prescription data for beta-blockers from January 2018 to June 2023 were extracted through the Hospital Prescription Analysis Collaborative Project in China to analyze clinical usage trends. While adverse drug reaction reports for beta-blockers were obtained from the FDA Adverse Event Reporting System (FAERS) database. The classification and standardization of adverse drug event (ADE) reports were based on the preferred terms (PT) and corresponding system organ classes (SOC) from the Medical Dictionary for Regulatory Activities (MedDRA). Signal detection utilized a proportion imbalance method. RESULTS: In clinical practice, metoprolol dominated beta-blocker prescriptions in China, accounting for 62.2%. Beta-blockers were primarily prescribed to the elderly (65.7%) and male patients (57.0%). However, off-label use of beta-blockers was relatively widespread. For instance, sotalol was prescribed for hypertension at 18.25%, while esmolol was used for angina and heart failure at rates of 12.94% and 14.98%, respectively. In addition, we identified newly discovered adverse reactions associated with beta-blockers, such as BRASH syndrome (metoprolol: n = 186, ROR = 391.285; carvedilol: n = 72, ROR = 256.459), acute kidney injury (bisoprolol: n = 247, ROR = 5.641), premature baby (labetalol: n = 110, ROR = 91.385), and sleep disorder (propranolol: n = 254, ROR = 10.98). CONCLUSIONS: Metoprolol led the beta-blocker market in China. Attention was warranted regarding the newly discovered adverse reactions, such as the risk of acute kidney injury with bisoprolol and the potential for BRASH syndrome with metoprolol and carvedilol.
Yan et al. (Thu,) conducted a observational in Cardiovascular conditions (hypertension, heart failure, angina, arrhythmias) (n=5,928,173). Beta-blockers was evaluated on Proportion of total beta-blocker prescriptions. Metoprolol dominated beta-blocker prescriptions in China at 62.2%, while safety analysis identified new adverse reaction signals including BRASH syndrome for metoprolol (ROR 391.285).