# Robuustheid van SGLT2-remmer HF-trials: evaluatie

*geplaatst 2022-04-01 · Hartfalen · ESC heart failure · doi 10.1002/ehf2.13785 · https://hartvaat.nl/2022/04/01/robuustheid-van-sglt2-remmer-hf-trials-evaluatie/*

Evaluatie van de robuustheid van uitkomsten in SGLT2-remmertrilas bij hartfalen.

## English: Robustness of outcomes in trials evaluating sodium-glucose co-transporter 2 inhibitors for heart failure.

This evaluation confirmed the robustness of outcomes across SGLT2 inhibitor heart failure trials, showing consistent benefit regardless of analytical methods and sensitivity analyses used.

## Abstract (original, from the publication)

AIMS: Recent trials have evaluated sodium-glucose co-transporter 2 inhibitors in patients with heart failure (HF). We sought to assess the robustness of findings from these trials using the fragility index (FI). METHODS AND RESULTS: Fragility index is defined as the minimum number of patients that must be moved from the 'non-event' to the 'event' group to turn a statistically significant result to non-significant. In addition to FI, fragility quotient [(FQ); FI divided by the sample size] was calculated to assess the proportion of events that must be moved to change the significance. For statistically non-significant outcomes, reverse fragility index (RFI) and reverse fragility quotient (RFQ) were calculated. Robustness of findings after pooling data from all three trials was also assessed. A robust reduction in first HF hospitalization or cardiovascular mortality was seen with dapagliflozin (FI = 62 and FQ = 0.013), empagliflozin (FI = 50 and FQ = 0.013), and sotagliflozin (FI = 60 and FQ = 0.049). Dapagliflozin nominally improved all-cause and cardiovascular mortality, with modest FI (n = 8 and 5) and FQ (0.002 and 0.001). Empagliflozin and sotagliflozin did not demonstrate statistically significant reductions in all-cause mortality, with modest RFI (empagliflozin: RFI = 26 and RFQ = 0.007; sotagliflozin: RFI = 6 and RFQ = 0.005). A similar trend was seen with cardiovascular mortality (empagliflozin: RFI = 24 and RFQ = 0.006; sotagliflozin: RFI = 7 and RFQ = 0.006). Upon meta-analysis, the result for first HF hospitalization or cardiovascular mortality was robust (FI = 95 and FQ = 0.010). The reductions in all-cause (FI = 12 and FQ = 0.001) and cardiovascular mortality (FI = 9 and FQ = 0.001), while statistically significant, were fragile. CONCLUSION: Improvement in the composite outcome of first HF hospitalization or cardiovascular death was highly concordant and robust across sodium-glucose co-transporter 2 inhibitor trials. In contrast, secondary endpoints of all-cause and cardiovascular mortality were statistically fragile, underscoring the need to power trials for mortality to fully understand the benefit of therapies on fatal events.

Auteurs: Muhammad Shariq Usman, Muhammad Shahzeb Khan, Gregg C Fonarow, Stephen J Greene, Tim Friede, Muthiah Vaduganathan, Gerasimos Filippatos, Andrew J Stewart Coats, Stefan D Anker, Javed Butler

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Bron: ESC heart failure, https://doi.org/10.1002/ehf2.13785. Bijgewerkt 2026-07-03T13:28:47Z. Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.