The Association of Suspected Adverse Drug Reactions with Patients Receiving Atorvastatin or Rosuvastatin in A Tertiary Care Hospital.
1
Research Scholar, Department of Pharmacology, TMMC&RC, Teerthanker Mahaveer University, Moradabad (U.P), India
2
Professor, Department of Pharmacology, TMMC&RC, Teerthanker Mahaveer University, Moradabad (U.P), India
Received: 2025-07-21
Revised: 2025-08-30
Accepted: 2025-09-15
Published: 2025-09-30
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.
Statins, Atorvastatin, Rosuvastatin, Adverse Drug Reactions, Pharmacovigilance, Musculoskeletal disorders, Gender difference, India.