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Farmacologia
Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction.
McMurray JJV, et al. · 2019
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🛡️ Lavora su: Protezione d'organo · lente Traiettoria · il corpo nel tempo
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RCT (prova forte)
La domandaIn pazienti con scompenso cardiaco a frazione di eiezione ridotta, dapagliflozin riduce il peggioramento dello scompenso e la morte cardiovascolare, indipendentemente dal diabete?
Cosa hanno trovatoRCT di fase 3, placebo-controllato, n=4744 (2373 vs 2371), NYHA II-IV con FE <=40%, in aggiunta alla terapia raccomandata; follow-up mediano 18,2 mesi. Outcome primario (peggioramento scompenso o morte CV): 16,3% vs 21,2%; HR 0,74 (IC 95% 0,65-0,85; P<0,001). Peggioramento scompenso: 10,0% vs 13,7%; HR 0,70 (0,59-0,83). Morte CV: 9,6% vs 11,5%; HR 0,82 (0,69-0,98). Mortalita totale: 11,6% vs 13,9%; HR 0,83 (0,71-0,97). Risultati simili con e senza diabete. Eventi avversi da deplezione di volume, disfunzione renale e ipoglicemia non differivano tra i gruppi.
Cosa significa per teIn chi ha scompenso cardiaco con cuore che pompa poco (FE ridotta), questo SGLT2 inibitore ha ridotto ricoveri per scompenso e morti CV, anche in assenza di diabete: e un beneficio cardiologico, non solo glicemico. Prova forte (RCT ampio di fase 3). La terapia dello scompenso e decisione del cardiologo/diabetologo. Studio non condotto nel diabete tipo 1.
Abstract (in lingua originale)
BACKGROUND: In patients with type 2 diabetes, inhibitors of sodium-glucose cotransporter 2 (SGLT2) reduce the risk of a first hospitalization for heart failure, possibly through glucose-independent mechanisms. More data are needed regarding the effects of SGLT2 inhibitors in patients with established heart failure and a reduced ejection fraction, regardless of the presence or absence of type 2 diabetes. METHODS: In this phase 3, placebo-controlled trial, we randomly assigned 4744 patients with New York Heart Association class II, III, or IV heart failure and an ejection fraction of 40% or less to receive either dapagliflozin (at a dose of 10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of worsening heart failure (hospitalization or an urgent visit resulting in intravenous therapy for heart failure) or cardiovascular death. RESULTS: Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the placebo group (hazard ratio, 0.74; 95% confidence interval [CI], 0.65 to 0.85; P<0.001). A first worsening heart failure event occurred in 237 patients (10.0%) in the dapagliflozin group and in 326 patients (13.7%) in the placebo group (hazard ratio, 0.70; 95% CI, 0.59 to 0.83). Death from cardiovascular causes occurred in 227 patients (9.6%) in the dapagliflozin group and in 273 patients (11.5%) in the placebo group (hazard ratio, 0.82; 95% CI, 0.69 to 0.98); 276 patients (11.6%) and 329 patients (13.9%), respectively, died from any cause (hazard ratio, 0.83; 95% CI, 0.71 to 0.97). Findings in patients with diabetes were similar to those in patients without diabetes. The frequency of adverse events related to volume depletion, renal dysfunction, and hypoglycemia did not differ between treatment groups. CONCLUSIONS: Among patients with heart failure and a reduced ejection fraction, the risk of worsening heart failure or death from cardiovascular causes was lower among those who received dapagliflozin than among those who received placebo, regardless of the presence or absence of diabetes. (Funded by AstraZeneca; DAPA-HF ClinicalTrials.gov number, NCT03036124.).
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Come leggerlo: è uno studio scientifico peer-reviewed. Le evidenze aiutano a capire i trend, ma un singolo studio non è una prescrizione: parlane col tuo diabetologo prima di cambiare dieta o terapia.