Diskuterades på EASD, Empagliflozin (Jardiance®) SGLT2-hämmare

 

Empa minskade i RCT den kombinerade risken för kardiovaskulär död eller sjukhusinläggningar pga hjärtsvikt med 25% jämfört med placebo utöver standardbehandling hos hjärtsviktspatienter med nedsatt vänsterkammarfunktion (HFrEF) med eller utan T2DM.  

 

Number Needed to Treat, NNT är så lågt som 19 i denna studie 

 

Dessutom visades att att empa gav signifikant 30% minskad risk för första och återkommande sjukhusinläggning för hjärtsvikt och en sign långsammare njurfunktionsnedsättning. 

 

Published August 20, 2020

 

 

Abstract

BACKGROUND

Sodium–glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes.

More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction.

METHODS

In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy.

The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure.

RESULTS

During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P<0.001).

The effect of empagliflozin on the primary outcome was consistent in patients regardless of the presence or absence of diabetes.

The total number of hospitalizations for heart failure was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.70; 95% CI, 0.58 to 0.85; P<0.001).

The annual rate of decline in the estimated glomerular filtration rate was slower in the empagliflozin group than in the placebo group (–0.55 vs. –2.28 ml per minute per 1.73 m² of body-surface area per year, P<0.001), and empagliflozin-treated patients had a lower risk of serious renal outcomes.

Uncomplicated genital tract infection was reported more frequently with empagliflozin.

CONCLUSIONS

Among patients receiving recommended therapy for heart failure, those in the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure than those in the placebo group, regardless of the presence or absence of diabetes.

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DAPA-HF studien är gjord på dapagliflozin (Forxiga®), en annan SGLT2-I och har också Results for Non-Diabetic and Diabtic Patients vid hjärtsvikt och med jämförbara resultat.  

EMPEROR-Reduced hade EF i det lägre intervallet och visar att SGLT2-I har fördelar också hos patienter med mer avancerad hjärtsvikt. 

https://www.acc.org/latest-in-cardiology/clinical-trials/2019/08/30/21/33/dapa-hf

 

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