General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Medical Research and Education, Taipei Veterans General Hospital, Taipei, Taiwan; Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan; Institute of Public Health, National Yang-Ming University, Taipei, Taiwan.
Am J Cardiol. 2014 Feb 15;113(4):631-6. doi: 10.1016/j.amjcard.2013.10.043. Epub 2013 Nov 23.
The Food and Drug Administration recently updated the safety warning concerning the association between statin therapy and new-onset diabetes mellitus (NODM). For prediabetes, little information is available for statins on cardiovascular outcome reduction and diabetogenic consequences. This study aimed to examine the risk of NODM and the reduction of cardiovascular events and death (MACE) after statin therapy in the prediabetic subjects. The medical and pharmacy claims of the prediabetic beneficiaries were retrieved from Taiwan National Health Insurance research database. The occurrence of NODM, MACE, and morbidity indexed by hospitalizations and emergency visits was ascertained by ambulatory and inpatient database. A propensity score-matched model was constructed for statin users and nonusers. During follow-up (4.1 ± 2.5 years), NODM and MACE occurred in 23.5% and 16.7%, respectively, of nonusers and 28.5% and 12.0%, respectively, of users. Statin therapy was associated with a greater risk of NODM (hazard ratio 1.20, 95% confidence interval 1.08 to 1.32) and less risk of MACE (hazard ratio 0.70, 95% confidence interval 0.61 to 0.80), both in dose-dependent fashions. The earlier and more persistent use correlated with the greater increase in risk of NODM offset by the proportionally larger reduction in MACE. Furthermore, the early persistent users had the lowest rate of hospitalizations and emergency visits. In conclusion, our findings suggested that the relation between NODM and therapeutic advantages of statins was parallel in the prediabetic population. Treatment benefits outweighed diabetic consequences in subjects receiving the earlier and more persistent treatment.
美国食品和药物管理局最近更新了他汀类药物治疗与新发糖尿病(NODM)之间关联的安全性警告。对于前驱糖尿病,关于他汀类药物对心血管结局的降低和致糖尿病后果,几乎没有信息。本研究旨在检查前驱糖尿病患者接受他汀类药物治疗后发生 NODM 和心血管事件及死亡(MACE)的风险。从台湾全民健康保险研究数据库中检索出前驱糖尿病受益人的医疗和药物索赔。通过门诊和住院数据库确定 NODM、MACE 和以住院和急诊就诊为索引的发病率。为他汀类药物使用者和非使用者构建倾向评分匹配模型。在随访(4.1±2.5 年)期间,非使用者中分别有 23.5%和 16.7%发生 NODM 和 MACE,而使用者中分别有 28.5%和 12.0%发生 NODM 和 MACE。他汀类药物治疗与 NODM 的风险增加(风险比 1.20,95%置信区间 1.08 至 1.32)和 MACE 的风险降低(风险比 0.70,95%置信区间 0.61 至 0.80)相关,两者均呈剂量依赖性。早期和持续使用与 NODM 风险增加成正比,而 MACE 风险降低比例更大。此外,早期持续使用者的住院和急诊就诊率最低。总之,我们的研究结果表明,前驱糖尿病患者中 NODM 与他汀类药物治疗优势之间的关系是平行的。在接受更早和更持续治疗的患者中,治疗益处超过了糖尿病的后果。