Alatorre Carlos I, Hoogwerf Byron J, Deeg Mark A, Nelson David R, Hunter Theresa M, Ng Wee Teck, Rekhter Mark D
a Eli Lilly and Company , Indianapolis , IN , USA.
b Eli Lilly and Company, Lilly NUS Center for Clinical Pharmacology , Singapore.
Curr Med Res Opin. 2018 Feb;34(2):337-343. doi: 10.1080/03007995.2017.1396969. Epub 2017 Nov 24.
The objective of this study was to identify factors associated with stroke, myocardial infarction (MI), all-cause mortality, or a diagnosis of ischemic heart disease (IHD) or unstable angina (UA), among patients newly-diagnosed with type 2 diabetes (T2DM) with no recent history of cardiovascular (CV) events who rapidly achieve and maintain HbA ≤8.0%.
Data were obtained from the Clinical Practice Research Datalink (CPRD) from January 1990 to December 2012. A nested case-control design was used with Cox proportional hazards analysis. Cases were identified by the first occurrence of stroke, MI, IHD, UA, or death within 5 years after HbA ≤ 8.0% was first reached (index date) following T2DM diagnosis. Controls were selected using a risk-set sampling approach and were matched 4:1 to cases using index date, exposure time, age, gender, and HbA at index date.
A total of 11,426 T2DM patients met the inclusion criteria for cases. Of these, 5,261 experienced a CV event. Stroke was the most frequent CV event (40%), followed by IHD (29%), MI (22%), and UA (9%). Mean HbA1c ≥7.0% over the length of exposure (vs 6.5 to <7.0%) was associated with an increased risk of stroke, MI, and IHD. The use of anti-platelet medications at baseline was also associated with increased risk of stroke (HR = 1.82 [CI = 1.60-2.06]), MI (HR = 1.67 [CI = 1.38-2.03]), and IHD (HR = 1.85 [CI = 1.57-2.17]). Mean HbA1c < 6.0% was associated with increased risk of stroke (HR = 1.29 [CI = 1.02-1.63]) and IHD (HR = 1.65 [CI = 1.25-2.19]). Use of nitrate medications at baseline was associated with increased risk of MI (HR = 2.83 [CI = 2.24-3.57]), IHD (HR = 4.32 [CI = 3.57-5.22]), and UA (HR = 10.38 [CI = 7.67-14.03]).
Early and sustained HbA control between 6.5 and <7.0% appears to be an important modifiable factor that helps reduce CV risk in patients with newly-diagnosed T2DM in real-world clinical practice.
本研究的目的是在新诊断为2型糖尿病（T2DM）且近期无心血管（CV）事件病史、能迅速达到并维持糖化血红蛋白（HbA）≤8.0%的患者中，确定与中风、心肌梗死（MI）、全因死亡率、或缺血性心脏病（IHD）或不稳定型心绞痛（UA）诊断相关的因素。
数据取自1990年1月至2012年12月的临床实践研究数据链（CPRD）。采用巢式病例对照设计及Cox比例风险分析。病例通过在T2DM诊断后首次达到HbA≤8.0%（索引日期）后的5年内首次发生中风、MI、IHD、UA或死亡来确定。对照组采用风险集抽样方法选取，并根据索引日期、暴露时间、年龄、性别和索引日期时的HbA与病例按4:1进行匹配。
共有11426例T2DM患者符合病例纳入标准。其中，5261例发生了CV事件。中风是最常见的CV事件（40%），其次是IHD（29%）、MI（22%）和UA（9%）。暴露期间平均糖化血红蛋白（HbA1c）≥7.0%（vs 6.5至<7.0%）与中风、MI和IHD风险增加相关。基线时使用抗血小板药物也与中风（风险比[HR]=1.82[置信区间（CI）=1.60-2.06]）、MI（HR=1.67[CI=1.38-2.03]）和IHD（HR=1.85[CI=1.57-2.17]）风险增加相关。平均HbA1c<6.0%与中风（HR=1.29[CI=1.02-1.63]）和IHD（HR=1.65[CI=1.25-2.19]）风险增加相关。基线时使用硝酸盐药物与MI（HR=2.83[CI=2.24-3.57]）、IHD（HR=4.32[CI=3.57-5.22]）和UA（HR=10.38[CI=7.67-14.03]）风险增加相关。
在现实临床实践中，将HbA早期且持续控制在6.5至<7.0%之间似乎是一个重要的可改变因素，有助于降低新诊断T2DM患者的CV风险。
