The combination Sacubitril/valsartan did not reduce the risk of rehospitalization for heart failure or cardiovascular death in patients with cardiac failure symptoms and preserved ejection fraction, according to the new study presented on Sunday at ESC 2019 scientific session in Paris and simultaneously published in NEJM.
Despite the negative results, we remain hopeful that this drug could bridge the gap in the treatment of this population on the rise.
After a mean 3 year follow up, primary end point rate every 100 patients/year was 12.8 with valsartan/sacubritil vs. 14.6 for valsartan alone (RR 0.87, CI 95% 0.75 to 1.01). A favorable trend, but with no significance.
Secondary end points, of exploratory nature, showed improved functional class and quality of life together with lower chance of kidney function deterioration with the sacubitril/valsartan combination.
At sub-group analysis, it seems to have a special benefit in women. This does not come as a surprise since it is women who most frequently present cardiac failure with preserved function.
This drug combination has been approved for patients with chronic cardiac failure with reduced ejection fraction (40% or lower) based on the PARADIGM-HF outcomes. In this study, the combination sacubritil/valsartan was indeed capable of reducing cardiovascular death rate and rehospitalization for cardiac failure.
Despite the PARAGON-HF outcomes, we should not lose hope on the benefit of these drugs for patients with preserved function, seeing as no drugs have been proved effective in this context.
Original title: Angiotensin-neprilysin inhibition in heart failure with preserved ejection fraction.
Reference: Solomon SD et al. N Engl J Med. 2019; Epub ahead of print.
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