Efficacy of HMG-CoA reductase inhibitors in the prevention of cerebrovascular attack in 1016 patients older than 75years among 4014 type 2 diabetic individuals

Efficacy of HMG-CoA reductase inhibitors in the prevention of cerebrovascular attack in 1016 patients older than 75years among 4014 type 2 diabetic individuals
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HMG-CoA还原酶抑制剂预防4014名2型糖尿病患者中1016名75岁以上患者脑血管发作的疗效

DOI:
10.1016/j.ijcard.2014.10.093
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发表时间:
2014
期刊:
影响因子:
3.5
通讯作者:
on behalf of Japan CDM group
on behalf of Japan CDM group
中科院分区:
医学2区
文献类型:
--
作者:
Hayashi T;Kubota K;Kawashima S;Sone H;Watanabe H;Ohrui T;Yokote K;Takemoto M;Araki A;Noda M;Noto H;Sakuma I;Yoshizumi M;Ina K;Nomura H;on behalf of Japan CDM group

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背景/目的HMG-CoA还原酶抑制剂(他汀类药物)可减少中年糖尿病患者的缺血性心脏病(IHD),而低密度脂蛋白胆固醇(LDL-C)是一个危险因素。然而,尚未确定其对老年人脑血管病发作(CVA)的预防作用,特别是在≥ 75岁的老年人(老年晚期)中,他们占日本糖尿病患者的约30%。他汀类药物的随机对照研究很难进行,因为老年人的许多并发症破坏随机对照conditions.MethodsWe进行了一项前瞻性队列研究(日本胆固醇和糖尿病研究),自2004年以来的5.5年随访。共入组了4014例既往无IHD或CVA的2型糖尿病患者(n = 1936例女性;年龄= 67.4 ± 9.5岁; ≥ 75岁:n = 1016),而405例患者登记为子队列患者。我们记录了亚队列中患有IHD或CVA的患者每次改变药物后的详细药物信息和实验室数据。我们细分他汀类药物用户到流行,新的和非users.ResultsA共104 CVAs发生在5.5年。≥ 65岁患者血浆HDL-C水平与CVA呈负相关。在病例对照研究中,在未使用他汀类药物的患者中,CVA以年龄依赖性方式增加。流行和新他汀类药物使用者的CVA发生率低于非使用者(风险比[HR]:0.46,0.523),尤其是在老年晚期(HR:0.51,0.21)。他汀类药物减少CVA主要是由于直接作用,部分是由于HDL-C和葡萄糖代谢的影响。结论他汀类药物通过直接作用预防中、老年和晚老年糖尿病患者的CVA。这项研究首次证明了观察性研究在统计分析药物对老年人的影响方面的有用性。
Background/objectivesHMG-CoA reductase inhibitors (statins) reduce ischemic heart disease (IHD) in middle-aged diabetic individuals, and LDL-cholesterol (LDL-C) is a risk factor. However, their preventive effects on cerebrovascular attack (CVA) have not been identified in elderly, especially in elderly ≥ 75 years (late elderly), who account for approximately 30% of diabetic individuals in Japan. Randomized controlled studies of statins for late elderly are difficult to carry out, because many co-morbidities in elderly disrupt randomized controlled conditions.MethodsWe performed a prospective cohort study (Japan Cholesterol and Diabetes Mellitus Study) with 5.5 years of follow-up since 2004. A total of 4014 type 2 diabetic patients without previous IHD or CVA (n = 1936 women; age = 67.4 ± 9.5 years; ≥ 75 years: n = 1016) were enrolled, while 405 patients were registered as sub-cohort patients. We recorded detailed information on medications and laboratory data after every change in medication in patients of sub-cohort and suffered from IHD or CVA. We subdivided statin-users into prevalent, new and non-users.ResultsA total of 104 CVAs occurred during 5.5-years. Plasma HDL-C level was inversely correlated with CVA in patients ≥ 65 years. In case–control study, among patients who were not prescribed statins, CVA increased in age-dependent manner. CVA incidence was lower in prevalent and new statin-users than in non-users (hazard ratio [HR]:0.46, 0.523), especially in late elderly (HR: 0.51, 0.21). Statins reduced CVAs mainly due to a direct effect and partially due to the effects of HDL-C and glucose metabolism. No significant differences were observed between statins.ConclusionStatins prevented CVA in middle-aged, elderly and late elderly diabetic patients via a direct effect. This study is the first to demonstrate the usefulness of observational studies for statistically analyzing agents' effects on late elderly.