Matthew Nho

Background: Beta-blockers are widely prescribed across cardiovascular indications, yet their real-world cardiovascular adverse-event profiles across drug generations remain incompletely characterised in large pharmacovigilance datasets. Objective: The objective was to describe and compare cardiovascular adverse-event reporting patterns for atenolol, bisoprolol and nebivolol in the FDA Adverse Event Reporting System (FAERS). Methods: We performed a retrospective disproportionality analysis of FAERS reports using OpenVigil 2.1, covering each drug’s available reporting history from the first quarter of 2004 (2007 for nebivolol) through the third quarter of 2025 (FAERS 2025 Q3). Cardiovascular events were defined as individual MedDRA Preferred Terms; signals were assessed with the Reporting Odds Ratio (ROR, 95% CI) and Information Component (IC) under Evans’ criteria. Individual case safety reports were also analysed for demographics, seriousness and outcomes. Results: Atenolol was most strongly associated with bradycardia (ROR = 10.513), followed by pericardial haemorrhage (ROR = 7.067) and ventricular hypertrophy (ROR = 6.999). Bisoprolol showed the highest signals for diastolic dysfunction (ROR = 24.875), atrial tachycardia (ROR = 23.283) and chronic cardiac failure (ROR = 23.222). Nebivolol had the lowest overall reporting volume, although counts were not adjusted for exposure; its strongest signals were bradycardia (ROR = 9.619) and coronary artery stenosis (ROR = 9.351). Paediatric reports (0–17 years) were uncommon for atenolol and bisoprolol and nearly absent for nebivolol; none of the three is FDA-approved in this group. Reports mainly involved older adults (60–89 years), and a substantial proportion were classified as serious. Conclusions: All three agents generated significant signals across a broad range of cardiovascular events. Nebivolol had the lowest reporting volume, but this should not be interpreted as evidence of a safer profile. Because FAERS disproportionality cannot establish causality, these findings are hypothesis-generating and require prospective confirmation before they can inform beta-blocker selection.

Background: Beta-blockers are widely prescribed across cardiovascular indications, yet their real-world cardiovascular adverse-event profiles across drug generations remain incompletely characterized in large pharmacovigilance datasets. Objective: To compare the cardiovascular safety profiles of atenolol, bisoprolol and nebivolol using the FDA Adverse Event Reporting System (FAERS). Methods: Retrospective disproportionality analysis of FAERS reports via OpenVigil 2.1, covering each drug’s available reporting history through January 1st, 2026. Cardiovascular events were identified with Standardized MedDRA Queries; signals were assessed with the Reporting Odds Ratio (ROR, 95% CI) and Information Component (IC) under Evans’ criteria. Individual case safety reports were analysed for demographics, seriousness and outcomes. Results: Atenolol was most strongly associated with bradycardia (ROR = 10.513) and left ventricular hypertrophy (ROR = 6.765). Bisoprolol showed the highest signals for diastolic dysfunction (ROR = 24.875), atrial tachycardia (ROR = 23.283) and chronic cardiac failure (ROR = 23.222), together with the highest bradycardia-associated mortality (14.9%). Nebivolol had the lowest overall reporting burden, though counts are not exposure-adjusted; its strongest signals were bradycardia (ROR = 9.619) and coronary artery stenosis (ROR = 9.351), with lower bradycardia mortality (12.6%). Pediatric reports (0–17 years) occurred for all three agents at similar proportions, none FDA-approved in this group. Reports predominantly involved older adults (60–89 years), with a substantial proportion classified as serious. Conclusion: All three agents generated significant signals across a broad range of cardiovascular events, with nebivolol showing the most favourable profile. Because FAERS disproportionality cannot establish causality, these hypothesis-generating findings may inform beta-blocker selection in older or higher-risk patients, particularly those prone to bradyarrhythmias or diastolic dysfunction, pending prospective confirmation.

Bortezomib is a 26S proteasome inhibitor used to treat multiple myeloma and systemic amyloidosis. While effective in prolonging survival, bortezomib has been increasingly associated with cardiovascular adverse events (CVAEs), including cardiac failure and arrhythmias, yet a comprehensive post-marketing cardiac safety profile remains incompletely defined. We analyzed cardiovascular adverse events reported between May 2003 and May 2025 using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) via the OpenVigil 2.1 platform. Disproportionality analysis was performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs). Among over 9 million drug-related adverse events in FAERS, 552 cardiac events were linked to bortezomib. Several cardiac outcomes, including atrial flutter, left ventricular dysfunction, cardiac failure, cardiomyopathy, atrial fibrillation, right ventricular failure, myocarditis, and supraventricular tachycardia, demonstrated elevated disproportionality signals. Separately, cardiac amyloidosis exhibited the highest disproportionality signal (ROR: 35.58; 95% CI: 28.16–44.95), a finding that reflects underlying disease severity rather than treatment-emergent cardiotoxicity. Cardiac failure accounted for the greatest number of hospitalizations (301) and deaths (208), followed by atrial fibrillation and cardiac amyloidosis. Older adults (≥65 years) and patients with amyloidosis or multiple myeloma were the most vulnerable populations. Overall, bortezomib was associated with serious cardiac adverse events, particularly cardiac failure and atrial arrhythmias, underscoring the need for routine cardiovascular risk assessment and proactive monitoring in high-risk patients.

Bortezomib is a 26S proteasome inhibitor used to treat multiple myeloma and systemic amyloidosis. While effective in prolonging survival, bortezomib has been increasingly associated with cardiovascular adverse events (CVAEs), such as cardiac failure and arrhythmias. However, a comprehensive post-marketing safety profile has not been fully established. We analyzed cardiovascular adverse events reported between May 2003 and May 2025 using the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) via the Open Vigil 2.1 platform. Disproportionality analysis was conducted using the reporting odds ratio (ROR) with 95% confidence intervals (CI) to detect statistically significant adverse reports. Of over 9 million drug-related adverse events in the FAERS database, 552 Cardiac events were linked to bortezomib. Cardiac amyloidosis showed the strongest association (ROR: 35.58; 95% CI: 28.16–44.95), followed by atrial flutter (ROR: 4.34; 95% CI: 3.41–5.52), left ventricular dysfunction (ROR: 4.25; 95% CI: 3.26–5.55), cardiac failure, acute (ROR: 3.66; 95% CI: 2.75–4.86), congestive cardiomyopathy (ROR: 3.23; 95% CI: 2.33–4.49), hypertrophic cardiomyopathy (ROR: 3.44; 95% CI: 1.95–6.08), cardiac failure (ROR: 3.18; 95% CI: 2.93–3.46), cardiomyopathy (ROR: 2.81; 95% CI: 2.30–3.43), atrial fibrillation (ROR: 2.65; 95% CI: 2.43–2.89), right ventricular failure (ROR: 2.30; 95% CI: 1.63–3.24), myocarditis (ROR: 2.25; 95% CI: 1.73–2.91), and supraventricular tachycardia (ROR: 2.17; 95% CI: 1.61–2.93). cardiac failure led to the highest number of hospitalizations (301) and deaths (208), followed by atrial fibrillation and cardiac amyloidosis. Older adults (≥65 years) and patients with amyloidosis or myeloma were the most vulnerable groups. Bortezomib is associated with a wide spectrum of serious cardiac adverse events, with cardiac amyloidosis and cardiac failure demonstrating particularly high disproportionality and mortality. These findings emphasize the need for routine cardiovascular risk assessment and proactive monitoring in high-risk patient populations receiving bortezomib.