A study assessed whether the benefit of Sacubitril / Valsartan ( Entresto ) therapy varied with clinical stability.
Despite the benefit of Sacubitril / Valsartan therapy shown in the PARADIGM-HF ( Prospective Comparison of ARNI with ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure ) trial, it has been suggested that switching from an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker should be delayed until occurrence of clinical decompensation.
Outcomes were compared among patients who had prior hospitalization within 3 months of screening ( n = 1,611 [ 19% ] ), between 3 and 6 months ( n = 1,009 [ 12% ] ), between 6 and 12 months ( n = 886 [ 11% ] ), more than 12 months ( n = 1,746 [ 21% ] ), or who had never been hospitalized ( n = 3,125 [ 37% ] ).
Twenty percent of patients without prior heart failure hospitalization experienced a primary endpoint of cardiovascular death or heart failure hospitalization during the course of the trial.
Despite the increased risk associated with more recent hospitalization, the efficacy of Sacubitril / Valsartan therapy did not differ from that of Enalapril according to the occurrence of or time from hospitalization for heart failure before screening, with respect to the primary endpoint or with respect to cardiovascular or all-cause mortality.
In conclusion, patients with recent heart failure decompensation requiring hospitalization were more likely to experience cardiovascular death or heart failure hospitalization than those who had never been hospitalized.
Patients who were clinically stable, as shown by a remote heart failure hospitalization ( more than 3 months prior to screening ) or by lack of any prior heart failure hospitalization, were as likely to benefit from Sacubitril / Valsartan therapy as more recently hospitalized patients. ( Xagena )
Solomon SD et al, JACC Heart Fail 2016; Epub ahead of print