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<p>Bisoprolol, a selective β₁-blocker, is widely prescribed for cardiovascular disease. Real-world pharmacovigilance can clarify adverse drug reactions (ADRs) across demographic strata and identify signals not fully characterized in trials. We analyzed bisoprolol-associated reports in the FDA Adverse Event Reporting System. Disproportionality was assessed using complementary algorithms—reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC with IC025), and empirical Bayes geometric mean (EBGM with EBGM05). To stabilize sparse strata, we required <i>a</i> ≥ 3 and multi-algorithm concordance (EBGM05 &gt; 2, IC025 &gt; 0, lower95_ROR &gt; 1). Multiple testing was controlled using Benjamini–Hochberg FDR and Bonferroni adjustments. Signals were summarized overall and stratified by sex and age (&lt; 40, 40–80, ≥ 80&#xa0;years). Class-expected cardiovascular ADRs showed robust signals, including bradycardia, sinus bradycardia, bradyarrhythmia, atrioventricular block, hypotension, syncope/presyncope (all meeting stability and multiplicity criteria). Several hypothesis-generating signals with strong effect sizes were detected: cardiospasm (ROR≈285; EBGM05≈178), palmoplantar keratoderma (ROR≈217; EBGM05≈137), and hyperkalemia (ROR≈16.7; EBGM05≈13). Sex- and age-stratified analyses revealed clinically relevant patterns: in younger patients (&lt; 40), bradyarrhythmia-type signals were most pronounced; in middle-aged adults (40–80), cardiospasm and palmoplantar keratoderma ranked among the top signals; in older adults (≥ 80), conduction-slowing events remained prominent. Overall reporting skewed female (≈55%) and older age. A qualitative EudraVigilance cross-check identified parallel case clusters for cardiospasm and palmoplantar keratoderma, corroborating cross-jurisdictional presence. FAERS data reaffirm bisoprolol’s known bradycardic and hypotensive risks and highlight novel, biologically plausible signals—particularly cardiospasm and palmoplantar keratoderma—that vary by demographic subgroup. These findings support targeted clinical vigilance (heart-rate/conduction, electrolytes, dysphagia/chest pain, palmoplantar skin changes) and motivate confirmatory studies (prospective cohorts, nested case–controls). While robust to multiplicity control, signals remain hypothesis-generating given spontaneous-reporting biases; cautious interpretation and validation are warranted.</p>

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Real-world safety profile of bisoprolol: signal detection and demographic stratification using the FAERS database

  • 期刊论文

  • 发表日期：

    2025年10月3日

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  • Kun Lai,
  • Lan Luo,
  • Tengyao Kang,
  • Fuzhao Zhang,
  • Xinrong Chen

摘要

Bisoprolol, a selective β₁-blocker, is widely prescribed for cardiovascular disease. Real-world pharmacovigilance can clarify adverse drug reactions (ADRs) across demographic strata and identify signals not fully characterized in trials. We analyzed bisoprolol-associated reports in the FDA Adverse Event Reporting System. Disproportionality was assessed using complementary algorithms—reporting odds ratio (ROR), proportional reporting ratio (PRR), information component (IC with IC025), and empirical Bayes geometric mean (EBGM with EBGM05). To stabilize sparse strata, we required a ≥ 3 and multi-algorithm concordance (EBGM05 > 2, IC025 > 0, lower95_ROR > 1). Multiple testing was controlled using Benjamini–Hochberg FDR and Bonferroni adjustments. Signals were summarized overall and stratified by sex and age (< 40, 40–80, ≥ 80 years). Class-expected cardiovascular ADRs showed robust signals, including bradycardia, sinus bradycardia, bradyarrhythmia, atrioventricular block, hypotension, syncope/presyncope (all meeting stability and multiplicity criteria). Several hypothesis-generating signals with strong effect sizes were detected: cardiospasm (ROR≈285; EBGM05≈178), palmoplantar keratoderma (ROR≈217; EBGM05≈137), and hyperkalemia (ROR≈16.7; EBGM05≈13). Sex- and age-stratified analyses revealed clinically relevant patterns: in younger patients (< 40), bradyarrhythmia-type signals were most pronounced; in middle-aged adults (40–80), cardiospasm and palmoplantar keratoderma ranked among the top signals; in older adults (≥ 80), conduction-slowing events remained prominent. Overall reporting skewed female (≈55%) and older age. A qualitative EudraVigilance cross-check identified parallel case clusters for cardiospasm and palmoplantar keratoderma, corroborating cross-jurisdictional presence. FAERS data reaffirm bisoprolol’s known bradycardic and hypotensive risks and highlight novel, biologically plausible signals—particularly cardiospasm and palmoplantar keratoderma—that vary by demographic subgroup. These findings support targeted clinical vigilance (heart-rate/conduction, electrolytes, dysphagia/chest pain, palmoplantar skin changes) and motivate confirmatory studies (prospective cohorts, nested case–controls). While robust to multiplicity control, signals remain hypothesis-generating given spontaneous-reporting biases; cautious interpretation and validation are warranted.