How representative of a general type 2 diabetes population are patients included in cardiovascular outcome trials with SGLT2 inhibitors? A large European observational study

Kare I. Birkeland, Johan Bodegard*, Anna Norhammar, Josephina G. Kuiper, Elena Georgiado, Wendy L. Beekman-Hendriks, Marcus Thuresson, Marc Pignot, Ron M. C. Herings, Adriaan Kooy

*Corresponding author for this work

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    Abstract

    Aims Enrollment criteria vary substantially among cardiovascular outcome trials (CVOTs) of sodium-glucose cotransporter-2 inhibitors (SGLT-2is), which impacts the relationship between a trial population and the general type 2 diabetes (T2D) population. The aim of this study was to evaluate the representativeness of four SGLT-2i CVOTs of a general T2D population. Methods T2D patients from Germany, The Netherlands, Norway and Sweden were included in the study. Given the available data per country, key inclusion and exclusion criteria were defined by diagnoses, procedures and drug treatments to facilitate comparability among countries. Representativeness was determined by dividing the number of patients fulfilling the key enrolment criteria of each CVOT (CANVAS, DECLARE-TIMI 58, EMPA-REG OUTCOME, VERTIS-CV) by the total T2D population. Results In 2015, a total T2D population of 803 836 patients was identified in Germany (n = 239 485), in The Netherlands (n = 36 213), in Norway (n = 149 782) and in Sweden (n = 378 356). These populations showed a 25% to 44% cardiovascular (CV) disease baseline prevalence and high CV-preventive drug use (>80%). The general T2D population had less prevalent CV disease and patients were slightly older than those included in the CVOTs. The DECLARE-TIMI 58 trial had the highest representativeness, 59% compared to the general T2D population, and this representativeness was almost 2-, 3- and 4-fold higher compared to the CANVAS (34%), EMPA-REG OUTCOME (21%) and VERTIS-CV (17%) trials, respectively. Conclusions In large T2D populations within Europe, consistent patterns of representativeness of CVOTs were found when applying the main enrolment criteria. The DECLARE-TMI 58 trial had the highest representativeness, indicating that it included and examined patients who are most representative of the general T2D patients in the studied countries.

    Original languageEnglish
    Pages (from-to)968-974
    Number of pages7
    JournalDiabetes obesity & metabolism
    Volume21
    Issue number4
    DOIs
    Publication statusPublished - Apr-2019

    Keywords

    • cardiovascular disease
    • cardiovascular outcome trial
    • observational study
    • representativeness
    • SGLT2 inhibitors
    • GLUCOSE-LOWERING DRUGS
    • HEART-FAILURE
    • CVD-REAL
    • DAPAGLIFLOZIN
    • DIAGNOSIS
    • MORTALITY
    • ACCURACY
    • VALIDITY
    • DESIGN
    • RISK

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