General Clinical Research Center, Taipei Veterans General Hospital, Taipei, Taiwan, ROC; Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan, ROC; School of Medicine, National Yang-Ming University, Taipei, Taiwan, ROC.
Center for Geriatrics and Gerontology, Taichung Veterans General Hospital, Taichung, Taiwan, ROC; Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan, ROC.
J Chin Med Assoc. 2018 Mar;81(3):189-222. doi: 10.1016/j.jcma.2018.01.001. Epub 2018 Feb 13.
The global incidence and prevalence of type 2 diabetes have been escalating in recent decades. Patients with type 2 diabetes have an increased risk of atherosclerotic cardiovascular disease (ASCVD). About two-thirds of death in type 2 diabetes are due to ASCVD, including 40% from coronary heart disease (CHD), 15% from heart failure (HF), and 10% from stroke. The association between hyperglycemia and elevated CV risk has been demonstrated in multiple cohort studies. However, clinical trials of intensive glucose reduction did not significantly reduce macrovascular outcomes. It remains unclear whether the absence of demonstrable benefits is attributed to the inclusion of patients with far advanced ASCVD in whom a short treatment period is barely enough for CV protective effects to be shown, or complications associated with the treatment such as hypoglycemia hamper the beneficial effects to manifest, or simply glucose-lowering per se is ineffective. Since the US FDA issued a mandate in December 2008 that every new anti-diabetic agent requires rigorous assessments of its CV safety, there have been more than 200,000 patients enrolled in a number of randomized controlled trials (RCTs), and around half of them have been completed and published. The results of these CV outcome trials are important for clinicians in their clinical practice, and also provide an opportunity for academic society to formulate treatment guidelines or consensus to provide specific recommendations for glucose control in various CV diseases. The Taiwan Society of Cardiology (TSOC) and the Diabetes Association of Republic of China (DAROC), aiming to formulate a treatment consensus in type 2 diabetic patients with CVD, have appointed a jointed consensus group for the 2018 Consensus of TSOC/DAROC (Taiwan) on the Pharmacological Management of Patients with Type 2 Diabetes and CV Diseases. The consensus is comprised of 5 major parts: 1) Treatment of diabetes in patients with hypertension, 2) Treatment of diabetes in patients with CHD, 3) Treatment of diabetes in patients with stage 3 chronic kidney disease, 4) Treatment of diabetes in patients with a history of stroke, and 5) Treatment of diabetes in patients with HF. The members of the consensus group comprehensively reviewed all the evidence, mainly RCTs, and also included meta-analyses, cohort studies, and studies using claim data. The treatment targets of HbA1c were provided. The anti-diabetic agents were ranked according to their clinical evidence. The consensus is not mandatory. The final decision may need to be individualized and based on clinicians' discretion.
近年来,全球 2 型糖尿病的发病率和患病率一直在上升。2 型糖尿病患者发生动脉粥样硬化性心血管疾病(ASCVD)的风险增加。大约 2/3 的 2 型糖尿病死亡归因于 ASCVD,包括 40%死于冠心病(CHD)、15%死于心力衰竭(HF)和 10%死于中风。多项队列研究表明,高血糖与 CV 风险升高之间存在关联。然而,强化血糖降低的临床试验并未显著降低大血管结局。目前尚不清楚缺乏明显益处是归因于纳入了 ASCVD 进展非常严重的患者,在这些患者中,短期治疗几乎不足以显示 CV 保护作用,还是与治疗相关的并发症(如低血糖)阻碍了有益作用的显现,或者单纯的降血糖本身无效。自 2008 年 12 月美国食品和药物管理局(FDA)发布指令,要求每一种新的抗糖尿病药物都要严格评估其 CV 安全性以来,已有超过 20 万名患者参加了多项随机对照试验(RCT),其中约一半已完成并发表。这些 CV 结局试验的结果对临床医生的临床实践很重要,也为学术团体提供了一个机会,制定治疗指南或共识,为各种 CV 疾病中的血糖控制提供具体建议。为了制定患有 CVD 的 2 型糖尿病患者的治疗共识,台湾心脏病学会(TSOC)和中华民国糖尿病协会(DAROC)共同任命了一个联合共识小组,负责制定 2018 年 TSOC/DAROC(台湾)关于 2 型糖尿病和 CV 疾病患者药物治疗的共识。该共识由 5 个主要部分组成:1)高血压患者的糖尿病治疗,2)CHD 患者的糖尿病治疗,3)慢性肾脏病 3 期患者的糖尿病治疗,4)中风史患者的糖尿病治疗,以及 5)HF 患者的糖尿病治疗。共识小组的成员全面审查了所有证据,主要是 RCT,还包括荟萃分析、队列研究和使用索赔数据的研究。提供了 HbA1c 的治疗目标。根据临床证据对降糖药物进行了排名。该共识不具有强制性。最终决定可能需要个体化,并根据临床医生的判断。