{"id":"b254da630e51","type":"article","url":"https://hartvaat.nl/2022/04/01/robuustheid-van-sglt2-remmer-hf-trials-evaluatie/","title":"Robuustheid van SGLT2-remmer HF-trials: evaluatie","title_en":"Robustness of outcomes in trials evaluating sodium-glucose co-transporter 2 inhibitors for heart failure.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog","internist"],"tags":[],"journal":"ESC heart failure","doi":"10.1002/ehf2.13785","source_url":"https://doi.org/10.1002/ehf2.13785","authors":["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"],"significance":5,"published":"2022-04-01","source_date":"2022-04-01","image":"","kennis":["https://hartvaat.nl/kennis/hartfalen/hfref-hartfalen-met-verminderde-ejectie/","https://hartvaat.nl/kennis/hartfalen/sglt2-remmers-bij-hartfalen/"],"congress":"","summary_en":"This evaluation confirmed the robustness of outcomes across SGLT2 inhibitor heart failure trials, showing consistent benefit regardless of analytical methods and sensitivity analyses used.","created":"2026-07-03T10:29:40Z","updated":"2026-07-03T13:28:47Z","licence":"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.","body_markdown":"Evaluatie van de robuustheid van uitkomsten in SGLT2-remmertrilas bij hartfalen.","abstract_original":"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."}