Abstract
This study aimed to comprehensively evaluate the risk of respiratory, thoracic and mediastinal disorders associated with atorvastatin and rosuvastatin use. We conducted a retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database from Q1 2014 to Q1 2023. Disproportionality analysis was performed to quantify the risk of respiratory, thoracic and mediastinal disorders, using the reporting odds ratio (ROR), confidence interval (CI), information component (IC), and its lower 95% credibility interval (IC025). We also assessed the time to onset of these adverse events. We identified a total of 15,676 reports of respiratory, thoracic and mediastinal disorders linked to statins were identified. Atorvastatin (ROR = 2.05, 95% CI: 2.02-2.08, IC = 0.96, IC025 = 0.93) and rosuvastatin (ROR = 1.90, 95% CI: 1.87-1.93, IC = 0.86, IC025 = 0.82) both demonstrated significant associations with these adverse events. At the preferred term (PT) level, 63 positive signals were detected, with bronchial irritation (ROR = 43.31, 95% CI: 25.61-73.24; IC = 5.24, IC025 = 4.49) and prolonged expiration (ROR = 27.44, 95% CI: 16.92-44.50; IC = 4.65, IC025 = 3.90) showing the strongest signals. Middle-aged and elderly women (18-74 years) and elderly men (≥75 years) appeared to be at higher risk of developing respiratory, thoracic, and mediastinal disorders following statin use. With respect to the time to onset of these disorders, atorvastatin was associated with a median onset of 7 days, whereas rosuvastatin showed a longer median onset time of 14.5 days. This study suggests a significant association between atorvastatin and rosuvastatin and respiratory, thoracic, and mediastinal disorders. Overall, atorvastatin was associated with a higher risk; however, rosuvastatin exhibited stronger disproportionate signals in certain specific respiratory events, such as catarrh and nasal edema. Further studies are warranted to validate these findings and to elucidate the underlying mechanisms.