TY - JOUR
T1 - How representative of a general type 2 diabetes population are patients included in cardiovascular outcome trials with SGLT2 inhibitors? A large European observational study
AU - Birkeland, K. re I.
AU - Bodegard, Johan
AU - Norhammar, Anna
AU - Kuiper, Josephina G.
AU - Georgiado, Elena
AU - Beekman-Hendriks, Wendy L.
AU - Thuresson, Marcus
AU - Pignot, Marc
AU - Herings, Ron M. C.
AU - Kooy, Adriaan
N1 - Birkeland, Kare I Bodegard, Johan Norhammar, Anna Kuiper, Josephina G Georgiado, Elena Beekman-Hendriks, Wendy L Thuresson, Marcus Pignot, Marc Herings, Ron M C Kooy, Adriaan eng Observational Study Research Support, Non-U.S. Gov't England Diabetes Obes Metab. 2019 Apr;21(4):968-974. doi: 10.1111/dom.13612. Epub 2019 Jan 4.
PY - 2019/4/1
Y1 - 2019/4/1
N2 - 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.
AB - 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.
KW - Aged Aged, 80 and over Cardiovascular Diseases/complications/drug therapy/prevention & control Clinical Trials as Topic Diabetes Mellitus, Type 2/complications/drug therapy Female Germany Humans Male Middle Aged Netherlands Norway Patient Selection Sodium
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85059526723&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/30537226
U2 - 10.1111/dom.13612
DO - 10.1111/dom.13612
M3 - Article
C2 - 30537226
VL - 21
SP - 968
EP - 974
JO - Diabetes, Obesity and Metabolism
JF - Diabetes, Obesity and Metabolism
SN - 1462-8902
IS - 4
ER -