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他汀类糖尿病安全性工作组评估:2014 年更新。

An assessment by the Statin Diabetes Safety Task Force: 2014 update.

机构信息

Midwest Center for Metabolic & Cardiovascular Research and DePaul University, 6323 North Avondale Avenue, Suite 103, Chicago, IL 60631, USA.

Brigham and Women's Hospital and the Harvard Medical School, Boston, MA, USA.

出版信息

J Clin Lipidol. 2014 May-Jun;8(3 Suppl):S17-29. doi: 10.1016/j.jacl.2014.02.012.

Abstract

Statin therapy reduces the risk of myocardial infarction, stroke, and cardiovascular death by 25% to 30% in primary as well as secondary prevention patients. Thus, statins are the pharmacologic therapy of choice for the management of high blood cholesterol levels. Prompted by examination of clinical trial data suggesting a modest, but statistically significant, increase in the incidence of new-onset type 2 diabetes mellitus with statin use, the US Food and Drug Administration in 2012 added a statement to the labels of statin medications indicating that increases in glycated hemoglobin (HbA1C) and fasting glucose levels have been reported with statin use. This labeling change has raised questions among clinicians regarding the relative benefits and risks of statin use, both among patients with diabetes mellitus and among those with diabetes risk factors. This 2014 report from the Diabetes Subpanel of the National Lipid Association Expert Panel on Statin Safety reviews the published evidence relating statin use to the hazard for diabetes mellitus or worsening glycemia, examines potential mechanisms that may mediate the relationship between statin use and diabetes mellitus risk, and suggests future research efforts. Given the well-established benefits of statin therapy in the primary and secondary prevention of cardiovascular events among those with indications for treatment, no changes to clinical practice are recommended other than the measurement of HbA1C or fasting glucose in those deemed to also be at elevated diabetes risk after initiating statin therapy, and potentially before initiation in selected patients considered to be at elevated risk of developing diabetes. The panel advocates following recommendations from the American Diabetes Association, or other relevant guidelines if outside the United States, for screening and diagnosis as well as lifestyle modification for prevention or delay of diabetes mellitus in those with prediabetes or other risk factors.

摘要

他汀类药物治疗可降低一级和二级预防患者心肌梗死、中风和心血管死亡风险 25%至 30%。因此,他汀类药物是治疗高胆固醇血症的首选药物。美国食品和药物管理局 (FDA) 在 2012 年根据临床试验数据的检查结果,发现他汀类药物的使用与新诊断的 2 型糖尿病的发病率略有增加,但具有统计学意义,于是在他汀类药物标签上添加了一项声明,表明使用他汀类药物会导致糖化血红蛋白(HbA1C)和空腹血糖水平升高。这一标签变化引发了临床医生的疑问,即他汀类药物的使用在糖尿病患者和有糖尿病风险因素的患者中的相对获益和风险。国家脂质协会他汀类药物安全专家组糖尿病子组的这份 2014 年报告回顾了与他汀类药物使用与糖尿病风险相关的已发表证据,检查了可能介导他汀类药物使用与糖尿病风险之间关系的潜在机制,并提出了未来的研究方向。鉴于他汀类药物治疗在有治疗指征的患者中对心血管事件的一级和二级预防的益处已得到充分证实,除了在开始他汀类药物治疗后认为有升高的糖尿病风险的患者中测量 HbA1C 或空腹血糖,以及在某些被认为有升高的糖尿病风险的患者中在开始治疗前测量外,不建议改变临床实践,这些患者被认为有升高的糖尿病风险。专家组主张遵循美国糖尿病协会的建议,或在美国以外的情况下遵循其他相关指南,用于筛查和诊断以及生活方式改变,以预防或延迟糖尿病的发生。

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