Comparative Effectiveness and Safety of Moderate-Intensity Pravastatin Versus Atorvastatin in Patients with Dyslipidemia: A Retrospective Cohort Study Using a Common Data Model of Multicenter Electronic Health Records in South Korea
Year: 2025
Type: article
Study design: Observational Study
Abstract: AIM: To compare the effectiveness and safety of moderate-intensity pravastatin 40 mg/day and atorvastatin 10 mg/day in patients with dyslipidemia. METHODS: We conducted a retrospective cohort study using electronic health records of 19 million patients across 14 secondary/tertiary hospitals, standardized to a Common Data Model. New users of pravastatin (40 mg/day) and atorvastatin (10 mg/day) were identified. Six distinct cohorts were used to assess the comparative effectiveness in preventing major adverse cardiovascular events (MACE) and the risks of new-onset diabetes mellitus (NODM), myalgia or rhabdomyolysis, and hepatotoxicity (measured by aspartate aminotransferase [AST]/alanine aminotransferase [ALT]). Propensity score matching (PSM) was applied to each cohort for effectiveness and safety analyses, followed by a meta-analysis of hospital-specific results. RESULTS: After PSM, patients were equally assigned to the pravastatin and atorvastatin groups for primary (n = 2,688/group) and secondary MACE prevention (n = 1,258/group) and to assess the risk of NODM (n = 2,391/group), new-onset myalgia or rhabdomyolysis (n = 11,799/group), and hepatotoxicity (AST, n = 4,034/group; ALT, n = 3,655/group). No significant differences were observed in the hazard ratios (HRs) for primary (HR = 0.84; 95% CI, 0.59-1.20) and secondary MACE prevention (HR = 0.89; 95% CI, 0.68-1.16). Similarly, no significant difference was observed in the risk of NODM (HR, 0.99; 95% CI, 0.79-1.23). The risk of new-onset myalgia/rhabdomyolysis (HR = 0.82, 95% CI, 0.69-0.96) and the incidence of abnormal elevations in AST levels (2.35% vs. 3.37%, p＜0.05) were significantly lower in the pravastatin group. CONCLUSION: Moderate-intensity pravastatin (40 mg/day) showed comparable effectiveness to moderate-intensity atorvastatin (10 mg/day) in preventing MACE with a more favorable safety profile.
DOI: 10.5551/jat.65345
Institutions: Soonchunhyang University, Soonchunhyang University Hospital Cheonan, Ajou University, Korea University, Korea University, Kyung Hee University, Kyung Hee University Medical Center, Hallym University, Inha University, Pusan National University Hospital, CHA University Bundang Medical Center, Kangdong Sacred Heart Hospital, CHA University, Inha University Hospital, Pusan National University, Gyeongsang National University, Gyeongsang National University Hospital, Ewha Womans University, Ewha Womans University Medical Center, Ewha Womans University Seoul Hospital, Soonchunhyang University Hospital Bucheon, Daiichi-Sankyo (South Korea), Kyung Hee University Hospital at Gangdong
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
Funder: Daiichi Sankyo Europe
OpenAlex ID: W4410198754