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Journal of Rare Cardiovascular Diseases
ISSN: 2299-3711 (Print)
e-ISSN: 2300-5505 (Online)
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The Association of Suspected Adverse Drug Reactions with Patients Receiving Atorvastatin or Rosuvastatin in A Tertiary Care Hospital.
Yash Goel
,  
Prithpal Singh Matreja
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Abstract
Background: Statins, primarily atorvastatin and rosuvastatin, are widely prescribed lipid-lowering agents proven to reduce cardiovascular morbidity and mortality. However, concerns regarding adverse drug reactions (ADRs), especially musculoskeletal complaints, often affect patient compliance and long-term outcomes. Comparative real-world data on their safety profiles in Indian clinical settings remain limited. Objective: To study the association of suspected ADRs with patients receiving atorvastatin or rosuvastatin in a tertiary care hospital Methods: A prospective cross-sectional study was conducted in the Department of Pharmacology at Teerthanker Mahaveer Medical College and Research Centre, Moradabad, India. A total of 290 adult patients who received either atorvastatin or rosuvastatin and subsequently reported suspected ADRs were enrolled. Data were collected using a validated ADR reporting form. Causality was assessed using the WHO-UMC scale, while seriousness and outcome were evaluated per PvPI and ICH guidelines. Statistical analyses included Chi-square tests and binary logistic regression, with p<0.05 considered significant. Results: Among 290 patients, 191 experienced suspected ADRs, while 99 did not. Musculoskeletal disorders, including myopathy, joint pain, and limb discomfort, were the most commonly reported ADRs. Male patients exhibited a significantly higher incidence of ADRs than females (p<0.001). Logistic regression revealed that rosuvastatin was associated with significantly fewer ADRs than atorvastatin (p=0.005), indicating superior tolerability. The dose of statins did not show a statistically significant correlation with ADR occurrence (p=0.097). Conclusion: Rosuvastatin demonstrated a better safety profile compared to atorvastatin, with a significantly lower incidence of suspected ADRs, particularly musculoskeletal symptoms. The unexpected gender disparity and lack of dose-ADR association highlight the complexity of statin-related adverse effects. These findings support the preferential use of rosuvastatin in patients at higher risk for intolerance. Further large-scale, multi-centric studies are warranted to validate these observations and guide personalized statin therapy.
Keywords
Statins, Atorvastatin, Rosuvastatin, Adverse Drug Reactions, Pharmacovigilance, Musculoskeletal disorders, Gender difference, India.
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Classification of Rare Cardiovascular Diseases anticoagulation atrial fibrillation atrial septal defect cardiomyopathy computed tomography congenital heart disease echocardiography electrocardiogram electrocardiography heart failure implantable cardioverter‑defibrillator magnetic resonance imaging pregnancy pulmonary arterial hypertension pulmonary hypertension rare cardiovascular disease rare disease right heart catheterization right ventricular failure
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