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<p>Ethnic variations in lifestyle, diet, and pharmacogenetics significantly influence statin tolerance. Extending our previous work that documented overall ADR incidence, this study introduces a Hierarchical Risk Assessment Framework (HRAF) to systematically compare statin safety profiles through multi-layered statistical analysis and network visualization. We conducted a post-hoc pooled analysis of Chinese clinical trials (1992–2023) involving seven statins. Our triple-analytical HRAF comprised: (1) global 2 × 7 contingency analysis using Chi-squared tests; (2) individual statin risk profiling with Bonferroni-corrected pairwise comparisons against aggregate controls; and (3) comprehensive pairwise comparisons with Tukey adjustment and network visualization. Muscle-related (189 study units; <i>n</i> = 31,763) and liver-related (188 study units; <i>n</i> = 31,281) adverse drug reactions were analyzed. Applying the HRAF consistently revealed distinct statin-specific safety hierarchies. Global tests confirmed significant class heterogeneity (both <i>p</i> &lt; 0.001). Individual profiling identified atorvastatin with elevated myopathy risk (1.78%; Bonferroni <i>p</i> &lt; 0.001) and pitavastatin with pronounced hepatotoxicity (5.36%; Bonferroni <i>p</i> &lt; 0.001) alongside significant myopathy risk (2.53%; Bonferroni <i>p</i> = 0.002). Pairwise comparisons established detailed risk gradients: atorvastatin showed higher myopathy risk versus five statins (all Tukey <i>p</i> &lt; 0.001 except pitavastatin), while pitavastatin demonstrated superior hepatotoxicity risk versus all comparators (all Tukey <i>p</i> &lt; 0.001) and significant myopathy risk versus multiple statins. Network analysis visually confirmed these high-risk statins as central nodes with multiple significant connections for both ADR types. Using this proposed HRAF provides robust, quantitative safety data for statins in Chinese patients, supporting risk-stratified prescribing that pitavastatin warrants heightened caution regarding liver function, while atorvastatin should be used judiciously in myopathy-susceptible patients. Rosuvastatin and simvastatin emerge as lower-risk alternatives for both outcomes.</p>

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A hierarchical risk assessment framework for head-to-head comparison of statin safety profiles in Chinese patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年4月9日

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  • Leo Tsui,
  • Dan Wang,
  • Chuyun Fan,
  • Chengling Shi

摘要

Ethnic variations in lifestyle, diet, and pharmacogenetics significantly influence statin tolerance. Extending our previous work that documented overall ADR incidence, this study introduces a Hierarchical Risk Assessment Framework (HRAF) to systematically compare statin safety profiles through multi-layered statistical analysis and network visualization. We conducted a post-hoc pooled analysis of Chinese clinical trials (1992–2023) involving seven statins. Our triple-analytical HRAF comprised: (1) global 2 × 7 contingency analysis using Chi-squared tests; (2) individual statin risk profiling with Bonferroni-corrected pairwise comparisons against aggregate controls; and (3) comprehensive pairwise comparisons with Tukey adjustment and network visualization. Muscle-related (189 study units; n = 31,763) and liver-related (188 study units; n = 31,281) adverse drug reactions were analyzed. Applying the HRAF consistently revealed distinct statin-specific safety hierarchies. Global tests confirmed significant class heterogeneity (both p < 0.001). Individual profiling identified atorvastatin with elevated myopathy risk (1.78%; Bonferroni p < 0.001) and pitavastatin with pronounced hepatotoxicity (5.36%; Bonferroni p < 0.001) alongside significant myopathy risk (2.53%; Bonferroni p = 0.002). Pairwise comparisons established detailed risk gradients: atorvastatin showed higher myopathy risk versus five statins (all Tukey p < 0.001 except pitavastatin), while pitavastatin demonstrated superior hepatotoxicity risk versus all comparators (all Tukey p < 0.001) and significant myopathy risk versus multiple statins. Network analysis visually confirmed these high-risk statins as central nodes with multiple significant connections for both ADR types. Using this proposed HRAF provides robust, quantitative safety data for statins in Chinese patients, supporting risk-stratified prescribing that pitavastatin warrants heightened caution regarding liver function, while atorvastatin should be used judiciously in myopathy-susceptible patients. Rosuvastatin and simvastatin emerge as lower-risk alternatives for both outcomes.