Aberle Jens, Duerschmied Daniel, Grond Martin, Lehrke Michael, Martin Stephan, Tröbs Sven-Oliver, Schultze Michael, Kossack Nils, Richter Lena Margareta, Gabler Maximilian
Universitätsklinikum Hamburg-Eppendorf (UKE), Martinistr. 52, 20246, Hamburg, Germany.
Cardiology, Angiology, Haemostaseology, and Medical Intensive Care, Medical Centre Mannheim, Medical Faculty Mannheim, European Center for AngioScience (ECAS), German Center for Cardiovascular Research (DZHK) partner site Heidelberg/Mannheim, Centre for Cardiovascular Acute Medicine Mannheim (ZKAM), Heidelberg University, Heidelberg, Germany.
Cardiovasc Diabetol. 2025 Sep 23;24(1):364. doi: 10.1186/s12933-025-02864-9.
Type 2 diabetes mellitus (T2DM) patients are at high risk for micro- and macrovascular complications, and cardiovascular (CV) events are a major cause of their increased risk of early death. Despite well-established treatment guidelines for the management of CV disease in T2DM, little is known about the real-world implementation of these guidelines.
To characterize the real-life treatment patterns of T2DM patients with an incident CV comorbidity in Germany, to establish whether treatment is in line with respective national guidelines, and to assess guideline adherence with respect to the occurrence of serious clinical outcomes.
This was a retrospective observational study using claims data from the WIG2 benchmark database including more than 4.5 million insured individuals. T2DM-prevalent patients with an incident CV comorbidity (ischemic stroke, myocardial infarction [MI], heart failure, or coronary artery disease) were identified between 2016 and 2018. Data on patient demographics and comorbidities were collected at baseline. During follow-up, data on treatment patterns and medical outcomes (all-cause mortality, modified 3P-MACE [composite endpoint of all-cause death or inpatient diagnosis of MI or stroke]) were captured. Guideline adherence was assessed using the medication possession ratio and was categorized as completely, partly or non-adherent.
Overall, 17,175 T2DM patients with a mean age of 71.1 years experiencing an incident CV comorbidity during the study period were identified. The most frequently prescribed CV treatments during follow-up were renin-angiotensin-aldosterone system inhibitors (83.9%), diuretics (72.6%) and beta-blocking agents (71.8%). Around 40% of the study population were treated completely adherent to the respective CV guidelines. These patients had a significantly higher chance of survival compared to patients not treated in line with the guidelines (90.8% vs. 82.6% survival within 12 months follow-up). Patients not treated according to CV guidelines had a higher mortality and 3P-MACE risk vs. patients completely adherent to guidelines (HR 1.93, 95% CI 1.65-2.25 and HR 1.49, 95% CI 1.31-1.69, respectively).
The results from this claims database study provide important insights into real-world management of CV comorbidities in T2DM patients in Germany and underline that inconsistent guideline adherence is a major unmet challenge to healthcare providers.
2型糖尿病(T2DM)患者发生微血管和大血管并发症的风险很高,心血管(CV)事件是其早期死亡风险增加的主要原因。尽管T2DM患者心血管疾病管理的治疗指南已很成熟,但对于这些指南在现实世界中的实施情况却知之甚少。
描述德国患有新发CV合并症的T2DM患者的实际治疗模式,确定治疗是否符合各自的国家指南,并评估关于严重临床结局发生情况的指南依从性。
这是一项回顾性观察研究,使用了来自WIG2基准数据库的理赔数据,该数据库包含超过450万参保个体。在2016年至2018年期间,识别出患有新发CV合并症(缺血性中风、心肌梗死[MI]、心力衰竭或冠状动脉疾病)的T2DM患者。在基线时收集患者人口统计学和合并症数据。在随访期间,收集治疗模式和医疗结局(全因死亡率、改良3P-MACE[全因死亡或住院诊断为MI或中风的复合终点])的数据。使用药物持有率评估指南依从性,并将其分类为完全、部分或不依从。
总体而言,在研究期间确定了17175例平均年龄为71.1岁的T2DM患者发生了新发CV合并症。随访期间最常处方的CV治疗药物是肾素-血管紧张素-醛固酮系统抑制剂(83.9%)、利尿剂(72.6%)和β受体阻滞剂(71.8%)。大约40%的研究人群的治疗完全符合各自的CV指南。与未按照指南治疗的患者相比,这些患者的生存机会显著更高(随访12个月内生存率分别为90.8%和82.6%)。与完全遵循指南的患者相比,未按照CV指南治疗的患者死亡率和3P-MACE风险更高(风险比分别为1.93,95%置信区间1.65-2.25和1.49,95%置信区间1.31-1.69)。
这项理赔数据库研究的结果为德国T2DM患者CV合并症的现实世界管理提供了重要见解,并强调指南依从性不一致是医疗保健提供者面临的一个主要未满足的挑战。