TY - JOUR
T1 - External applicability of SGLT2 inhibitor cardiovascular outcome trials to patients with type 2 diabetes and cardiovascular disease
AU - Smidt, Lisanne C.A.
AU - Visseren, Frank L.J.
AU - de Ranitz-Greven, Wendela L.
AU - Nathoe, Hendrik M.
AU - Kappelle, L. Jaap
AU - de Borst, Gert J.
AU - de Valk, Harold W.
AU - Westerink, Jan
N1 - Funding Information:
The UCC-SMART study was financially supported by a grant of the University Medical Center Utrecht. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Funding Information:
We gratefully acknowledge the contribution of the research nurses; R. van Petersen (data-manager); B. van Dinther (study manager) and the members of the Utrecht Cardiovascular Cohort-Second Manifestations of ARTerial disease-Studygroup (UCC-SMART-Studygroup): F.W. Asselbergs and H.M. Nathoe, Department of Cardiology; G.J. de Borst, Department of Vascular Surgery; M.L. Bots and M.I. Geerlings, Julius Center for health Sciences and Primary Care; M.H. Emmelot, Department of Geriatrics; P.A. de Jong and T. Leiner, Department of Radiology; A.T. Lely, Department of Obstetrics & Gynecology; N.P. van der Kaaij, Department of Cardiothoracic Surgery; L.J. Kappelle and Y.M. Ruigrok, Department of Neurology; M.C. Verhaar, Department of Nephrology, F.L.J. Visseren (chair) and J. Westerink, Department of Vascular Medicine, University Medical Center Utrecht and Utrecht University.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Recent treatment guidelines support the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes and cardiovascular disease based on the results of cardiovascular outcome trials (CVOTs). Applicability of these trials to everyday patients with type 2 diabetes and cardiovascular disease is however unknown. The aim of this study is to assess the external applicability of SGLT2i CVOTs in daily clinical practice type 2 diabetes patients with established cardiovascular disease. Methods: Trial in- and exclusion criteria from EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58 and VERTIS-CV were applied to 1389 type 2 diabetes patients with cardiovascular disease in the Utrecht Cardiovascular Cohort-Secondary Manifestations of ARTerial disease (UCC-SMART). To evaluate the difference in cardiovascular risk (MACE) and all-cause mortality between trial eligible and ineligible patients, age and sex-adjusted Cox-regression analyses were performed. Results: After applying trial in- and exclusion criteria, 48% of UCC-SMART patients with type 2 diabetes and cardiovascular disease would have been eligible for DECLARE-TIMI 58, 35% for CANVAS, 29% for EMPA-REG OUTCOME and 21% for VERTIS-CV. Without the eligibility criteria of HbA1c, eligibility was 58–88%. For all trials the observed risk for cardiovascular events and all-cause mortality was similar in eligible and ineligible patients after adjustment for age and gender. Conclusion: A large proportion of patients with type 2 diabetes and cardiovascular disease in daily clinical practice would have been eligible for participation in the SGLT2i CVOTs. Trial eligible and ineligible patients have the same risk for MACE and all-cause mortality.
AB - Background: Recent treatment guidelines support the use of sodium-glucose cotransporter 2 inhibitors (SGLT2i) in patients with type 2 diabetes and cardiovascular disease based on the results of cardiovascular outcome trials (CVOTs). Applicability of these trials to everyday patients with type 2 diabetes and cardiovascular disease is however unknown. The aim of this study is to assess the external applicability of SGLT2i CVOTs in daily clinical practice type 2 diabetes patients with established cardiovascular disease. Methods: Trial in- and exclusion criteria from EMPA-REG OUTCOME, CANVAS, DECLARE-TIMI 58 and VERTIS-CV were applied to 1389 type 2 diabetes patients with cardiovascular disease in the Utrecht Cardiovascular Cohort-Secondary Manifestations of ARTerial disease (UCC-SMART). To evaluate the difference in cardiovascular risk (MACE) and all-cause mortality between trial eligible and ineligible patients, age and sex-adjusted Cox-regression analyses were performed. Results: After applying trial in- and exclusion criteria, 48% of UCC-SMART patients with type 2 diabetes and cardiovascular disease would have been eligible for DECLARE-TIMI 58, 35% for CANVAS, 29% for EMPA-REG OUTCOME and 21% for VERTIS-CV. Without the eligibility criteria of HbA1c, eligibility was 58–88%. For all trials the observed risk for cardiovascular events and all-cause mortality was similar in eligible and ineligible patients after adjustment for age and gender. Conclusion: A large proportion of patients with type 2 diabetes and cardiovascular disease in daily clinical practice would have been eligible for participation in the SGLT2i CVOTs. Trial eligible and ineligible patients have the same risk for MACE and all-cause mortality.
KW - Applicability
KW - Cardiovascular disease
KW - Cardiovascular outcome trial
KW - Sodium-glucose cotransporter 2 inhibitor
KW - Type 2 diabetes
UR - http://www.scopus.com/inward/record.url?scp=85114651716&partnerID=8YFLogxK
U2 - 10.1186/s12933-021-01373-9
DO - 10.1186/s12933-021-01373-9
M3 - Article
C2 - 34496847
SN - 1475-2840
VL - 20
JO - Cardiovascular Diabetology
JF - Cardiovascular Diabetology
IS - 1
M1 - 181
ER -