Abstract
Introduction: Sodium-glucose co-transporter 2 inhibitors (SGLT2i) have been shown to reduce cardiovascular (CV) risk in patients with type 2 diabetes. Trial results reported as hazard ratios (HR) may be of limited use in shared decision-making. Restricted mean survival time (RMST) is an alternative reported in time units and can be easily interpreted. Hypothesis: We sought to investigate the effects of SGLT2i on CV outcomes using RMST in pivotal trials in patients with type 2 diabetes. Methods: Data from 5 trials of SGLT2i (CANVAS, CREDENCE, EMPAREG-OUTCOME, DECLARE-TIMI 58, VERTIS CV) for the following end-points: major adverse cardiovascular events (MACE: myocardial infarction, stroke, and cardiovascular death), heart failure hospitalizations (HFH), cardiovascular death and all-cause mortality was extracted from the Kaplan Meier curves. For each trial, we calculated the RMST difference (ΔRMSTs) between SGLT2i and placebo arms, which were then pooled using random effect models. Results for all trials were extrapolated till 7 years (CANVAS trial maximum follow-up), when necessary, using flexible parametric model Results: Four trials were included for MACE (CANVAS, EMPAREG OUTCOME, VERTIS CV, DECLARE TIMI 58). dRMST for MACE increased non-linearly over time from year 1 (1.2 [0.2-2.2] days) to year 7 (19.5 [5.3-33.8] days). For HFH (CANVAS, EMPAREG OUTCOME, VERTIS CV), dRMST increased non-linearly from year 1 (1.2 [0.7-1.7] days) to year 7 (26.3 [15.2-37.3] days), Figure. For CV death (CANVAS, CREDENCE, EMPAREG OUTCOME, VERTIS CV), dRMST increased non-linearly from year 1 (0.6 [0.2-1.1] days) to year 7 (34.8 [3.3-66.4] days). For all-cause mortality (CANVAS, CREDENCE, EMPAREG OUTCOME, DECLARE-TIMI 58), dRMST increased non-linearly from year 1 (0.2 [-0.1-0.6] days) to year 7 (39.1 [2.8-75.5] days). Conclusions: SGLT2i are associated with a statistically significant, time-dependent, non-linear delay in MACE, HFH, cardiovascular and all-cause deaths.
Published Version
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