Chien-Yi Hsu1,2,3,4, Yung-Tai Chen1,5, Yu-Wen Su2,6, Chun-Chin Chang1,2,7, Po-Hsun Huang1,2,8, Shing-Jong Lin1,2,3,9. 1. Institute of Clinical Medicine, National Yang-Ming University, Taipei 112, Taiwan. 2. Cardiovascular Research Center, National Yang-Ming University, Taipei 112, Taiwan. 3. Department of Internal Medicine, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan. 4. Division of Cardiology and Cardiovascular Research Center, Department of Internal Medicine, Taipei Medical University Hospital, Taipei 110, Taiwan. 5. Department of Medicine, Taipei City Hospital, Heping Fuyou Branch, Taipei 100, Taiwan. 6. Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital, Taipei 112, Taiwan. 7. Taipei Veterans General Hospital, Taoyuan Branch, Taoyuan 330, Taiwan. 8. Division of Cardiology, Taipei Veterans General Hospital, Taipei 112, Taiwan. 9. Department of Medical Research, Taipei Veterans General Hospital, Taipei 112, Taiwan.
Abstract
Context: Although there is evidence to support the beneficial effects of statins on major cardiovascular events, few studies address the protective effect of statins on limb outcome. Objective: To investigate whether the use of statin is associated with a risk reduction in lower-extremity amputation in type 2 diabetes mellitus (DM) patients with peripheral arterial disease (PAD). Design: Observational cohort study. Setting: A nationwide DM database in Taiwan from 2000 to 2011. Patients: A total of 69,332 patients aged ≥20 years with DM and PAD were identified. Intervention: Patients were divided into three groups: 11,409 patients were statin users, 4430 patients used nonstatin lipid-lowering agents, and 53,493 patients were nonusers. Main Outcome Measures: The primary outcome was lower-extremity amputation. Secondary outcomes were in-hospital cardiovascular death and all-cause mortality. Results: Compared with nonusers, statin users were associated with lower risks of lower-extremity amputation [adjusted hazard ration (aHR), 0.75; 95% confidence interval (CI), 0.62 to 0.90], in-hospital cardiovascular death (aHR, 0.78; 95% CI, 0.69 to 0.87), and all-cause mortality (aHR, 0.73; 95% CI, 0.69 to 0.77). In the propensity score matching analysis, the effect of statin on the risk of lower-extremity amputation was consistent. Only statin users were associated with the risk reduction of lower-extremities amputation (HR, 0.77; 95% CI, 0.61 to 0.97) and cardiovascular death (HR, 0.78; 95% CI, 0.68 to 0.89) when taking competing risk of death into consideration. Conclusions: Compared with statin nonusers who were never treated with lipid-lowering drugs, this study found that statin users had a lower risk of lower-extremity amputation and cardiovascular death in patients with DM and PAD.
Context: Although there is evidence to support the beneficial effects of statins on major cardiovascular events, few studies address the protective effect of statins on limb outcome. Objective: To investigate whether the use of statin is associated with a risk reduction in lower-extremity amputation in type 2 diabetes mellitus (DM) patients with peripheral arterial disease (PAD). Design: Observational cohort study. Setting: A nationwide DM database in Taiwan from 2000 to 2011. Patients: A total of 69,332 patients aged ≥20 years with DM and PAD were identified. Intervention: Patients were divided into three groups: 11,409 patients were statin users, 4430 patients used nonstatin lipid-lowering agents, and 53,493 patients were nonusers. Main Outcome Measures: The primary outcome was lower-extremity amputation. Secondary outcomes were in-hospital cardiovascular death and all-cause mortality. Results: Compared with nonusers, statin users were associated with lower risks of lower-extremity amputation [adjusted hazard ration (aHR), 0.75; 95% confidence interval (CI), 0.62 to 0.90], in-hospital cardiovascular death (aHR, 0.78; 95% CI, 0.69 to 0.87), and all-cause mortality (aHR, 0.73; 95% CI, 0.69 to 0.77). In the propensity score matching analysis, the effect of statin on the risk of lower-extremity amputation was consistent. Only statin users were associated with the risk reduction of lower-extremities amputation (HR, 0.77; 95% CI, 0.61 to 0.97) and cardiovascular death (HR, 0.78; 95% CI, 0.68 to 0.89) when taking competing risk of death into consideration. Conclusions: Compared with statin nonusers who were never treated with lipid-lowering drugs, this study found that statin users had a lower risk of lower-extremity amputation and cardiovascular death in patients with DM and PAD.
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