Acute myocardial infarction (MI), a severe manifestation of coronary artery disease, remains a predominant cause of cardiovascular mortality and heart failure worldwide. Recent data reveal that MI occurs in 3.8% of individuals under 60 years of age and escalates to 9.5% among those over 60 years of age [3]. The definition of MI has evolved significantly. In 2012, it was expanded to include any ischemic event that causes cardiac myocyte death, leading to the identification of five pathological types [4]. Further refinements in 2018 have spurred ongoing debates on its clinical classifications and practical application [5–8].
Advances in MI prognosis in the past decade are primarily attributed to improved preventive and therapeutic strategies. These include improved risk factor management, the broader use of invasive procedures, and advancements in antithrombotic therapies. Statins have played a critical role in secondary prevention measures [9, 10].
MI typically results from the rupture of an atherosclerotic plaque or endothelial erosion within coronary arteries, highlighting the importance of reducing low-density lipoprotein cholesterol (LDL-C) through medication as a cornerstone of post-MI management [11]. Despite the introduction of new treatments such as PCSK9 inhibitors and siRNAs, statins remain the first-line therapy following ischemic events. First approved in 1987, statins have demonstrated consistent efficacy and safety in various demographic and clinical settings [12, 13]. Beyond lowering LDL-C, statins are recognized for providing additional cardiovascular benefits such as improved endothelial function, reduced inflammation, and beneficial effects on mitochondria [14].
Despite their benefits, statins are linked to multiple adverse effects, including insulin resistance, type-2 diabetes, myopathy, and pro-calcifying actions [15–18]. The influence of statins on post-MI depression is also under investigation. While some initial studies suggested that statins might mitigate depression symptoms, more recent research disputes their effectiveness in this role as a standalone treatment [19–21]. The broader spectrum of statin-related adverse events (AEs) and their implications in MI patient management remains poorly defined. Furthermore, the appropriateness of statin therapy for primary prevention in individuals aged 76 and older is still uncertain, with mixed clinical guidance reflecting this ambiguity [24]. Qualitative reports of symptoms such as shortness of breath, chest pain, and irregular heartbeats in statin users call for more rigorous quantitative investigation [25].
This study explores the relationship between statin use and cardiac adverse events (CAEs) using data from the FDA Adverse Event Reporting System (FAERS), a vital resource collecting spontaneous AE reports from manufacturers, healthcare professionals, and consumers [26, 27]. Such investigations are crucial for refining statin treatment protocols, ensuring they are effective and safe for personalized therapy in MI patients.
Aim
This pharmacovigilance study analyzed drug safety surveillance data from the FAERS dataset to investigate the association between statin use and CAEs.
Ethics approval
This study did not require ethics approval as no specific patient data was included.