Translating recent results from the Cardiovascular Outcomes Trials into clinical practice: recommendations from the Central and Eastern European Diabetes Expert Group (CEEDEG)

Abstract

AimsThese recommendations aim to improve care for patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk in Central and Eastern Europe. Cardiovascular disease (CVD) and/or chronic kidney disease (CKD) are major interdependent comorbidities in patients with T2D, accounting for 50% of mortality. Following recent CV outcomes trial (CVOT) results, including those from EMPA-REG OUTCOME®, LEADER®, SUSTAIN™-6 and, most recently, the CANVAS study, it is essential to develop regional expert consensus recommendations to aid physicians in interpreting these newest data to clinical practice.MethodsThe Central and Eastern European Diabetes Expert Group (CEEDEG) followed a Delphi method to develop treatment algorithms to aid physicians in the clinical management of patients with T2D at high CV risk.ResultsIn light of the latest CVOT results, and in particular the EMPA-REG OUTCOME® and LEADER® trials, the diagnosis, assessment, treatment choice and monitoring of patients with T2D and established CVD and/or CKD have been considered together with existing guidelines and presented in two reference algorithms. In addition, adherence, special prescribing considerations and a proposed multidisciplinary management approach have been discussed and are presented with the proposed algorithms.ConclusionsThe latest available high-level evidence on glucose-lowering drugs has enabled CEEDEG to develop practical consensus recommendations for patients with established CVD and/or CKD. These recommendations represent an update to international and country-level guidelines used for these patients, with the aim of providing a resource not only to endocrinologists, but to cardiologists, nephrologists and primary care physicians in the region.Electronic supplementary materialThe online version of this article (doi:10.1186/s12933-017-0622-7) contains supplementary material, which is available to authorized users.

Innovative highlights of clinical drug trial design

“…2,29 In this sense, a study design allows to examine beyond the intend-totreat disease, thus being re-purposed to an alternative indication according to the initial assignment upon lack of efficacy or safety issues 7 ; otherwise, a clinical trial can also be optimized to cover more therapeutic directions with the emerged evidence of certain additional efficacy. 24,30 In the era of precision medicine, there has been a consensus that therapeutic outcomes can vary significantly among subgroups of patients with differential genetic profiles. 2,27 Accordingly taking the advantage of interim analysis based on novel biomarker approach for detecting the pathogenesis-specific molecular alteration(s), an adaptive clinical study can select the drug-sensitive sub-population from patients with initially targeted disease or an alternative indication, to continue the investigation for an optimized therapeutic efficacy.…”

A consensual therapeutic recommendation for type 2 diabetes mellitus by the Slovak Diabetes Society (2018)

“…CVOT štúdie) do preferenčného výberu liečby u konkrétneho pacienta s cieľom znížiť konkrétne morbiditno-mortalitné riziko. V súčasnosti je takýto prístup aj súčasťou odporúčaní ADA/EASD, CEEDEG, CDA a ďalších [2,4,61].…”

CARMELINA: An important piece of the DPP-4 inhibitor CVOT puzzle

“…Cardiovascular disease (CVD) and chronic kidney disease (CKD) are comorbidities that are not only highly prevalent in patients with T2D but also largely responsible for the continued excess mortality in these patients [2]. By including patients with CVD at baseline, cardiovascular outcomes trials (CVOTs) have enabled clinicians to make evidence-based treatment decisions regarding the morbidity and mortality burden posed by CVD in patients with T2D [3]. However, until now, patients with CKD and renal outcomes had not been well represented in CVOTs [1].…”