Treatment and associated outcomes of type 2 diabetes mellitus patients with a cardiovascular comorbidity and comparison with guideline recommendations: a German claims data analysis.

Background: 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.

Objectives: 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.

Methods: 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.

Results: 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).

Conclusions: 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.