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How inclusive are diabetes cardiovascular outcomes trials?
Eligibility of patients with type 2 diabetes for sodium–glucose co-transporter-2 inhibitor cardiovascular outcomes trials: a global perspective from the DISCOVER study.
Cardiovascular outcomes trials (CVOTs) of sodium–glucose co-transporter-2 (SGLT-2) inhibitors have shown a significant reduction in the risk of cardiovascular events in patients with type 2 diabetes (T2D) using SGLT-2 inhibitors.1-3 However, eligibility of patients may vary greatly across the four completed or ongoing CVOTs:
Pintat S et al. have recently published a paper in BMJ Open Diabetes Research & Care,8 in which they compared the baseline characteristics of DISCOVER patients with the exclusion and inclusion criteria of CANVAS, DECLARE-TIMI 58, EMPA-REG OUTCOME and VERTIS-CV, to assess patient eligibility for CVOTs, overall and in four regions (Asia-Pacific, Europe, Latin America, and the Middle East and Africa).
The analysis included 11 385 DISCOVER patients with sufficient data. The authors found that, overall, DECLARE-TIMI 58 was the most inclusive CVOT followed by CANVAS, VERTIS-CV and EMPA-REG OUTCOME (Figure); results were consistent across regions. They also noted that 54.6% of DISCOVER patients, who have a relatively short duration of diabetes, were not eligible for any of the four CVOTs.
The authors concluded that findings from CVOTs are not equally generalizable. Although more recent CVOTs such as DECLARE-TIMI 58 included patients with lower cardiovascular risk than those enrolled in previous trials, efforts are required to include a more diverse population in future CVOTs of glucose-lowering drugs.
Figure. Estimated proportions of DISCOVER patients who would have been eligible for CANVAS, DECLARE-TIMI 58, EMPA-REG OUTCOME and VERTIS-CV.
The full open access paper is available here: https://drc.bmj.com/search/pintat%20jcode%3Abmjdrc.