| Summary: | 博士 === 國立陽明大學 === 公共衛生研究所 === 106 === Part I
Long-term effect of statins on the risk of new-onset osteoporosis: A nationwide population-based cohort study
Background: Several observational cohort and meta-analytical studies in humans have shown that statin users have a lower risk of fractures than nonusers. However, some studies including randomized clinical trials have the opposite results, particularly in Asian populations. This study investigates the impacts of statins on new-onset osteoporosis in Taiwan.
Methods: In a nationwide retrospective population-based cohort study, 45,342 subjects aged between 50–90 years having received statin therapy (statin-users) since January 1 2001, and observed through December 31 2013 were selected from the National Health Insurance Research Database of Taiwan. Likewise, 115,594 patients had no statin therapy (statin-non-users) were included as controls in this study. Multivariable Cox proportional hazards analysis for drug exposures was employed to evaluate the association between statin treatment and new-onset of osteoporosis risk. We also used the long-rank test to evaluate the difference of probability of osteoporosis-free survival.
Results: During the 13-year follow-up period, 16,146 of all enrolled subjects (10.03%) developed osteoporosis, including 3097 statin-users (6.83%) and 13,049 statin-non-users (11.29%). Overall, statin therapy reduced the risk of new-onset osteoporosis by 48% (adjusted hazard ratio [HR] 0.52; 95% CI 0.50 to 0.54). A dose-response relationship between statin treatment and the risk of new-onset osteoporosis was observed. The adjusted hazard ratios for new-onset osteoporosis were 0.84 (95% CI, 0.78 to 0.90), 0.56 (95% CI, 0.52 to 0.60) and 0.23 (95% CI, 0.21 to 0.25) when cumulative defined daily doses (cDDDs) ranged from 28 to 90, 91 to 365, and more than 365, respectively, relative to nonusers. Otherwise, high-potency statins (rosuvastatin and atorvastatin) and moderate-potency statin (simvastatin) seemed to have a potential protective effect for osteoporosis.
Conclusion: In this population-based cohort study, we found that statin use is associated with a decreased risk of osteoporosis in both genders. The osteoprotective effect of statins seemed to be more prominent with a dependency on the cumulative dosage and statin intensity.
Part II
High-Potency Statins But Not All Statins Decrease the Risk of New-Onset Osteoporotic Fractures: A Nationwide Population-Based Longitudinal Cohort Study
Background: Statins have been linked to new-onset osteoporotic fractures (NOFs), and different statins may alter the risk for the development of NOFs. In this study, we investigated the association between different statins and the development of NOFs.
Methods: This was a longitudinal cohort study performed using data from claim forms submitted to the Taiwan Bureau of National Health Insurance, including case patients with NOFs from January 2004 to December 2013 and non-NOF subjects. We estimated the hazard ratios (HRs) of NOFs associated with statin use. Non-user subjects served as the reference group.
Results: A total of 44,405 patients with NOFs were identified from among 170,533 patients with hyperlipidemia during the study period. The risk of developing NOFs after adjusting for age, sex, comorbidities, and concurrent medication use was higher among users of lovastatin (HR, 1.09; 95% confidence interval [CI], 1.02–1.15) than among nonusers. Patients who took atorvastatin (HR, 0.78; 95% CI, 0.74–0.82) and rosuvastatin (HR, 0.72; 95% CI, 0.65–0.80) were at lower risk of developing NOFs compared with nonusers. Simvastatin, pravastatin, fluvastatin, and pitavastatin were not associated with the risk of developing NOFs.
Conclusion: This study supports previous reports regarding a beneficial effect of statin use and NOF risk, but not all statins. Patients taking atorvastatin or rosuvastatin were at lower risk of developing NOFs, and the use of lovastatin was associated with a significantly increased risk of developing NOFs during the 10-year follow-up. This study also highlighted that high-potency statin has a dose-response effect on lower NOF risk.
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