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Empagliflozin reduces hospitalizations for heart failure in patients with HF and a left ventricular ejection fraction < 30%
Question clinique
In patients with heart failure with or without type 2 diabetes mellitus, does empagliflozin safely improve cardiovascular outcomes?
L’Essentiel
The authors state in their conclusion that "the empagliflozin group had a lower risk of cardiovascular death or hospitalization for heart failure." This is misleading. Patients who took the drug were less likely to be hospitalized for heart failure (HF), but there was no difference in the likelihood of cardiovascular death. Although benefit was seen in patients with and without diabetes, the benefit appears limited to patients with a left ventricular ejection fraction (LVEF) of less than 30% and is less impressive in white patients and patients who are obese. At a US cost of $500 per month (www.goodrx.com [November 3, 2020]), or $8000 over the 16-month study period, the number needed to treat (NNT) of 20 translates into a cost of $160,000 to prevent one hospitalization with no significant effect on mortality. 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Outpatient (any)
Sommaire
Previous studies have found that SGLT-2 inhibitors reduce the risk of hospitalization for HF, especially in those with a left ventricular ejection fraction (LVEF) of less than 30%. These researchers identified adults with Class II, III, or IV HF, an LVEF of less than 40%, and who were currently receiving standard therapy for HF; if the ejection fraction was between 30% and 40%, the patient also had to have been hospitalized for HF in the past 12 months or have a very elevated NT-proBNP level. Patients were then randomized to receive empagliflozin 10 mg or matching placebo and were followed up for a median 16 months. The groups were balanced at baseline, with a mean age of 67 years, mean LVEF of 27.5%, and 72% with an LVEF of less than 30%. Analysis was by intention to treat, and the primary outcome was the inappropriate composite of hospitalization for HF and cardiovascular death. The likelihood of hospitalization for HF was lower (13.2% vs 18.3%; hazard ratio [HR] 0.69, 95% CI 0.59 - 0.81; NNT = 20 over 16 months), but there was no difference in the likelihood of cardiovascular death (10.0% vs 10.8%; HR 0.92; 0.75 - 1.12) or all-cause mortality (13.4% vs 14.2%; HR 0.92; 0.77 - 1.10). The authors report a reduction in a composite renal outcome of dialysis, renal transplant, or sustained reduction in glomerular filtration rate (1.6% vs 3.1%; P < .05; NNT = 67 over 16 months). However, they do not report end-stage renal disease separately from biochemical changes, so it is not clear how to interpret the clinical importance of this effect. They also did a number of subgroup analyses, and report no significant benefit for white patients (HR 0.88; 0.75 - 1.04), obese patients (HR 0.85; 0.67 - 1.08), or those with an LVEF greater than 30% (HR 0.99; 0.76 - 1.31).
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Commentaires
HF improvement
I presume this is a class effect. Is it due to the diuresis?
empaglifozin and chf
too expensive and not enough benefit
Why is the Hype About Empagliflozin?
Are we getting Hoodwinked by Big Pharma when it comes to Empagliflozin
The pressure from the "ivory…
The pressure from the "ivory towers" is certainly that this class of drugs should be in the drinking water.
But so often the average patient is not the study patient. Multiple co-morbidities and not the same tertiary, study f/u in real life. So will the wonderful outcomes be the same? And so many talks gloss over the side effects as barely worth mentioning.
And the cost: i worry when MDs loudly proclaim that everyone should be on the latest most expensive drugs that we are exacerbating the gap between medicine for the well-to-do and the medicine for everyone else. Even when the new drug may not necessarily be that much better, the perception is that it is adn that breeds resentment and puts pressure on cash-strapped provinces to spend more of their budget for questionable clinical gains, just to calm the clamor.