gms | German Medical Science

Background: According to current guidelines, an appropriate drug treatment is the backbone for an effective management of cardiovascular (CV) comorbidities in patients with type 2 diabetes mellitus (T2DM).

Question and objective:The main objective of this study was to assess the degree of real-world adherence to these guideline recommendations, and to identify whether poor guideline adherence is associated with worse clinical outcomes.

Method: In this retrospective German claims data analysis (AOK PLUS dataset), T2DM-prevalent patients with an incident diagnosis of ischemic stroke (IS), myocardial infarction (MI), heart failure (HF) or coronary artery disease (CAD) were observed for 12 months between 01/01/2014 and 31/12/2016 (index date). We assessed three levels of guideline adherence per observed CV disease combination: “green” if patients received prescriptions of all recommended agents with >185 defined daily doses (DDDs) per observed patient year, “yellow” if patients received at least two prescriptions of at least one of the recommended agents, and “red” if patients did not receive at least two prescriptions of at least one of the recommended agents. The impact of the assignment of a patient to one of these three levels on all-cause mortality and CV-risk was analyzed based on multivariable Cox regression analyses and reported as adjusted hazard ratios (HRs).

Results: We identified 32,916 T2DM-prevalent patients with an incident CV comorbidity (mean age 75.0 years, 54.2% female, Charlson Comorbidity Index [CCI]: 5.5). Observed patients received at least 185 DDD of the following agent classes in the 12 months before/after index date: 6/6% VKAs, 9/27% antiplatelet drugs, 3/13% NOACs, 48/54% diuretics, 31/35% beta-blockers, 34/32% calcium-channel blockers, 69/68% RAAS-inhibitors and 19/37% lipid-modifying agents. When post-index therapy was compared to guideline recommendations, 14.4% of the patients could be classified as “green”, 75.2% as “yellow” and 10.5% as “red”. A “red” assignment was associated with worse CV outcomes in all analyses. With regard to mortality, in addition to age (HR 1.04), CCI (HR 1.17), use of insulins (HR 1.25), digitalis glycosides (HR 1.52) and diuretics (HR 1.32), non-adherence to guideline recommendations (“red”: HR 6.79 | “yellow”: HR: 1.30) was an important significant predictor for early death, while female gender (HR 0.79), the participation in a disease management program (HR 0.69) and the use of other ADs (HR 0.74) were generally associated with a reduced risk.

Discussion: Only a minority of patients with T2DM and an incident CV comorbidity received a treatment fully adherent with guideline recommendations. A drug treatment not in line with the guidelines was shown to be associated with substantially higher CV event rates as well as a higher mortality risk.

Praktische Implikationen: Suboptimal control of CV disease in T2DM patients may contribute to higher mortality rates in this population in clinical practice.

Appeal for practice (science and/or care) in one sentence: We strongly recommend monitoring drug treatment of this population in more detail and potentially including guideline-adherent treatment as an indicator for quality management in healthcare.