Evidence based medicine

 

Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction .

RCT - placebo control trial .

https://www.nejm.org/doi/full/10.1056/NEJMoa1911303.

P- Total 4744 patients with HFref .

2373- Dapagliflozin 10mg od .

2371 - placebo

I- Dapagliflozin vs placebo

C- Placebo 

O - 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.

1) 237 - In dapaglifozin grp had worsening heart failure and 227- Died.

2) 326- placebo had worsening HF

273- DIED .

CONCLUSION : 

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.

But pts who were included , dapagliflozon had more patients with NYHA class 2 and placebo had more pts with NYHA class 3,4 HF . Which can explain frequent hospital admissions in them .

 More larger data is required and they dint mention about what happened to other remaining patients .

And also all the patients received ARNI/ARB and beta blockers along with SGLT2 OR Placebo. 

So individual benefits couldn't be estimated .

But according to numbers they showed ,lesser hosp admissions and mortality was there for SLGT-2 group .

LIMITATIONS : 

This trial has some limitations. We used specific inclusion and exclusion criteria, which may have limited the generalizability of our findings. 

The baseline use of sacubitril–valsartan, which is more effective than renin–angiotensin system blockade alone at reducing the incidence of hospitalization for heart failure and death from cardiovascular causes, was low.