How similar are SGLT2i trial participants to your patients with T2D?

  • Castellana M & al.
  • Cardiovasc Diabetol
  • 13 Jun 2020

  • curated by Miriam Tucker
  • Clinical Essentials
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Takeaway

  • Real-world patients with type 2 diabetes (T2D) would be most likely to meet enrollment criteria for DECLARE-TIMI 58 compared with 3 other trials of cardiovascular outcomes.
  • This finding implies that dapagliflozin should be considered as the sodium-glucose co-transporter-2 inhibitor (SGLT2i) with the greatest generalizability potential among such trials.

Why this matters

  • Evaluating eligibility for these trials informs clinical practice.
  • Evidence from these trials of cardiovascular outcomes overall supports SGLT2i use in patients with T2D and a history of cardiovascular disease or risk factors.
  • Up to only 1 in 5 patients would meet enrollment criteria for these clinical trials.

Study design

  • Meta-analysis of 5 cardiovascular outcome trials; n=1,703,519.
  • Funding: None.

Key results

  • Prevalence of eligible patients in analytic cohorts according to enrollment criteria: 
  • In head-to-head comparisons of prevalence of eligibility, odds of meeting enrollment criteria:
    • DECLARE-TIMI 58 vs CANVAS: 1.74 (P=.003). 
    • DECLARE-TIMI 58 vs EMPA-REG OUTCOME: 5.15 (P<.001>
    • DECLARE-TIMI 58 vs VERTIS-CV: 4.81 (P<.001>
  • No difference was found between EMPA-REG OUTCOME and VERTIS-CV (P=.97).
  • High heterogeneity for all outcomes.

Limitations

  • Limited number of studies, countries.
  • Heterogeneity for all endpoints, reporting of baseline characteristics.  
  • Some baseline characteristics not reported.