Stiftung Institut für Herzinfarktforschung Ludwigshafen, Bremser Strasse 79, 67063, Ludwigshafen, Germany.
Cardiovasc Diabetol. 2012 Dec 5;11:148. doi: 10.1186/1475-2840-11-148.
Patients with type 2 diabetes have 2-4 times greater risk for cardiovascular morbidity and mortality than those without, and this is even further aggravated if they also suffer from hypertension. Unfortunately, less than one third of hypertensive diabetic patients meet blood pressure targets, and more than half fail to achieve target HbA1c values. Thus, appropriate blood pressure and glucose control are of utmost importance. Since treatment sometimes fails in clinical practice while clinical trials generally suggest good efficacy, data from daily clinical practice, especially with regard to the use of newly developed anti-diabetic and anti-hypertensive compounds in unselected patient populations, are essential. The DIALOGUE registry aims to close this important gap by evaluating different treatment approaches in hypertensive type 2 diabetic patients with respect to their effectiveness and tolerability and their impact on outcomes. In addition, DIALOGUE is the first registry to determine treatment success based on the new individualized treatment targets recommended by the ADA and the EASD.
DIALOGUE is a prospective observational German multicentre registry and will enrol 10,000 patients with both diabetes and hypertension in up to 700 sites. After a baseline visit, further documentations are scheduled at 6, 12 and 24 months. There are two co-primary objectives referring to the most recent guidelines for the treatment of diabetes and hypertension: 1) individual HbA1c goal achievement with respect to anti-diabetic pharmacotherapy and 2) individual blood pressure goal achievement with different antihypertensive treatments. Among the secondary objectives the rate of major cardio-vascular and cerebro-vascular events (MACCE) and the rate of hospitalizations are the most important.
The registry will be able to gain insights into the reasons for the obvious gap between the demonstrated efficacy and safety of anti-diabetic and anti-hypertensive drugs in clinical trials and their real world balance of effectiveness and safety.
患有 2 型糖尿病的患者发生心血管发病率和死亡率的风险是无糖尿病患者的 2-4 倍，如果他们同时患有高血压，这种风险会进一步增加。不幸的是，不到三分之一的高血压合并糖尿病患者的血压达标，超过一半的患者未能达到目标糖化血红蛋白值。因此，适当的血压和血糖控制至关重要。由于在临床实践中治疗有时会失败，而临床试验通常表明疗效良好，因此来自日常临床实践的数据，尤其是关于在未经选择的患者人群中使用新开发的抗糖尿病和抗高血压药物的疗效数据，是必不可少的。DIALOGUE 登记研究旨在通过评估高血压 2 型糖尿病患者的不同治疗方法在有效性和耐受性方面及其对结局的影响来填补这一重要空白。此外，DIALOGUE 是第一个根据 ADA 和 EASD 推荐的新个体化治疗目标来确定治疗成功的登记研究。
DIALOGUE 是一项前瞻性观察性德国多中心登记研究，将在多达 700 个地点招募 10000 名患有糖尿病和高血压的患者。在基线访视后，将在 6、12 和 24 个月时进行进一步的记录。有两个主要的次要目标，分别涉及糖尿病和高血压治疗的最新指南：1）抗糖尿病药物治疗时个体化糖化血红蛋白目标的实现，2）不同抗高血压治疗时个体化血压目标的实现。在次要目标中，最重要的是主要心血管和脑血管事件（MACCE）的发生率和住院率。
该登记研究将能够深入了解在临床试验中显示出的抗糖尿病和抗高血压药物的疗效和安全性与现实世界中这些药物的有效性和安全性之间明显差距的原因。
