Effectiveness of Sacubitril/Valsartan in Real-World Settings, With Stephen Greene, MD

Analysis of the GWTG-HF registry demonstrates the efficacy of sacubitril/valsartan in real-world settings. Study investigator Stephen Greene, MD, offers further perspective on the topic in an interview.

A new analysis of real-world data from patients hospitalized for heart failure with reduced ejection fraction (HFrEF) is underlining the benefits of prescribing the sacubitril/valsartan (Entresto) prior to hospital discharge in this patient population.

An analysis of Medicare beneficiaries aged 65 years and older from the Get with the Guidelines-Heart Failure (GWTG-HF) registry, results suggest use of sacubitril/valsartan was associated with a significantly lower risk of mortality and hospitalization compared to those not prescribed the agent, but investigators pointed out less than 11% of patients received a prescription during the study period.

Despite demonstrating an efficacy and safety profile worthy of FDA approval for HFrEF in 2015 and inclusion in recent guidelines, prescribing rates of sacubitril/valsartan remain subpar. Some point to skepticism surrounding effects in real-world vs. clinical trial settings as a factor hindering optimal prescription. With this in mind, investigators designed the current study to provide insight into the real-world use and benefits of sacubitril/valsartan.

Using the GWTG-HF registry, investigators identified 14,320 patients hospitalized for HFrEF from October 2015-December 2018 for inclusion. Inclusion criteria for the study included being aged 65 years or older, being discharged alive, having complete medical history, and having no contraindications to sacubitril/valsartan. Investigators noted October 2015 was chosen as the start date to allow a 3-month transition period after the FDA’s July 2015 approval of sacubitril/valsartan.

Of the 14,320 patients identified for inclusion, 1151 (10.9%) were prescribed sacubitril/valsartan at discharge. Of the 12,679 not prescribed sacubitril/valsartan at discharge, 7857 (62.0%) were prescribed an ACE inhibitor or ARB at discharge. Investigators pointed out prescribing rates for sacubitril/valsartan appeared to increase over time.

In analyses with inverse probability of treatment weighting and adjustment for other HFrEF medications, use of sacubitril/valsartan was independently associated with lower all‐cause mortality (aHR, 0.82; 95% CI, 0.72–0.94; P=.004), but not all‐cause hospitalization (aHR, 0.97; 95% CI, 0.89–1.07; P=.55) or heart failure hospitalization (aHR, 1.04; 95% CI, 0.91–1.18; P=.59) compared to use of ACEs/ARBs at 12 months. In analyses comparing use of sacubitril/valsartan vs. nonuse, results indicated patients receiving sacubitril/valsartan had a lower risk of all‐cause mortality (aHR, 0.69; 95% CI, 0.60–0.79; P <.001) and all‐cause hospitalization (aHR, 0.90; 95% CI, 0.82–0.98; P=.02), but not heart failure hospitalization (aHR, 0.94; 95% CI, 0.82–1.08; P=.40).

Investigators also pointed out sacubitril/valsartan had the lowest unadjusted incidences of 30-day and 12-month mortality compared to those receiving an ACE/ARB or neither therapy. Additionally, those receiving neither had the highest incidences of mortality at 30 days and 12 months.

For more, check out this clip from Practical Cardiology’s interview with lead investigator Stephen Greene, MD, assistant professor of medicine at Duke University School of Medicine.

This study, “Clinical Effectiveness of Sacubitril/Valsartan Among Patients Hospitalized for Heart Failure With Reduced Ejection Fraction,” was published in the Journal of the American Heart Association.