Pitavastatin use and risk of osteoporosis and osteoporotic fractures: A nationwide retrospective cohort study
Chao-Ming Chang, Wen-Tung Wu, Chun-Teng Tsai, Chih-Hui Chang, Wu-Chien Chien, Yu-Ching Chou, Cho-Hao Lee, Ming-Hsun LinBackground
Osteoporosis and dyslipidemia share overlapping pathophysiological mechanisms, and statins have been suggested to exert pleiotropic effects on bone metabolism. However, the comparative skeletal impact of individual statins, particularly pitavastatin, remains insufficiently characterized.
Objectives
To investigate the association between pitavastatin use and the risk of incident osteoporosis and osteoporotic fractures compared with other statins.
Design
Retrospective propensity score–matched cohort study (1:4 matching ratio).
Methods
Using Taiwan’s National Health Insurance Research Database, we identified patients aged 50–80 years with newly prescribed pitavastatin or other statins between 2014 and 2021. Individuals with prior osteoporosis or osteoporotic fractures were excluded. Propensity score matching was performed to adjust for age, sex, comorbidities, and co-medications. The primary outcome was a composite of newly diagnosed osteoporosis or osteoporotic fracture (hip, spine, or humeral/wrist), identified by ICD-9/10 codes. Adjusted hazard ratios (aHRs) were estimated using multivariable Cox proportional hazard regression models, several sensitivity analyses were conducted.
Results
Among 9,940 pitavastatin users and 39,760 matched other statin users, pitavastatin use was associated with a potentially lower risk of the composite outcome (aHR 0.72; 95% CI, 0.63–0.82). For subtype of composite outcome: osteoporosis (aHR 0.78; 95% CI, 0.63–0.97), hip fracture (aHR 0.64; 95% CI, 0.43–0.96), spine fracture (aHR 0.56; 95% CI, 0.41–0.76), and humeral/wrist fracture (aHR 0.79; 95% CI, 0.63–0.99). Risk reduction was observed across sex and age strata, most pronounced in patients aged 61–70 years (aHR 0.63; 95% CI, 0.51–0.79). Results remained consistent across multiple sensitivity analyses.
Conclusion
pitavastatin use was associated with a potentially lower risk of incident osteoporosis and osteoporotic fractures compared with other statins. The observational design precludes causal inference, and outcomes were ascertained through administrative codes without bone mineral density confirmation. These hypothesis-generating findings warrant confirmation in prospective studies incorporating direct bone health assessments.