Kato S, Miura M
Department of Pharmacy, Akita University Hospital, Akita, Japan.
J Clin Pharm Ther. 2018 Aug;43(4):536-542. doi: 10.1111/jcpt.12675. Epub 2018 Feb 26.
The risk of new-onset diabetes mellitus (NODM) in Japanese patients using low-dose hydroxymethyl glutaryl coenzyme A reductase inhibitors (statins) has not been previously examined. The aim of this study was to assess the risk of NODM associated with use of high- and low-potency statins in Japanese patients taking low-dose statins.
A retrospective cohort study of 2554 Japanese patients who started treatment with a statin was conducted. Only patients taking the same dose of the same statin were enrolled, and patients were separated into high- and low-potency statin groups. The outcome was incidence of NODM during statin treatment.
The incidence rate of NODM in the cohort was 7.4% (n = 190). Kaplan-Meier survival curves showed a significantly higher rate of NODM in patients taking high-potency statins compared with those taking low-potency statins (P < .001, log-rank test). Baseline fasting plasma glucose levels, use of high-potency statins, male gender and combination treatment with calcium channel blockers, immunosuppressants or steroids were identified as factors that significantly increased the risk for NODM using Cox proportional hazard regression analysis.
The use of high-potency statins at a low standard daily dose significantly increased the risk of NODM in Japanese patients compared with low-potency statins. Furthermore, clinicians should also be careful when prescribing statins in combination with steroids or immunosuppressants due to the increased risk of NODM.
此前尚未对日本患者使用低剂量羟甲基戊二酰辅酶A还原酶抑制剂(他汀类药物)时新发糖尿病(NODM)的风险进行过研究。本研究的目的是评估在服用低剂量他汀类药物的日本患者中,使用高效和低效他汀类药物与NODM风险之间的关联。
对2554例开始使用他汀类药物治疗的日本患者进行了一项回顾性队列研究。仅纳入服用相同剂量同一种他汀类药物的患者,并将患者分为高效和低效他汀类药物组。观察指标为他汀类药物治疗期间NODM的发生率。
该队列中NODM的发生率为7.4%(n = 190)。Kaplan-Meier生存曲线显示,与服用低效他汀类药物的患者相比,服用高效他汀类药物的患者NODM发生率显著更高(P <.001,对数秩检验)。使用Cox比例风险回归分析确定,基线空腹血糖水平、使用高效他汀类药物、男性性别以及与钙通道阻滞剂、免疫抑制剂或类固醇联合治疗是显著增加NODM风险的因素。
与低效他汀类药物相比,日本患者使用低标准日剂量的高效他汀类药物会显著增加NODM的风险。此外,由于NODM风险增加,临床医生在将他汀类药物与类固醇或免疫抑制剂联合处方时也应谨慎。