Eligibility of sacubitril–valsartan in a real‐world heart failure population: a community‐based single‐centre study

Abstract

AimsThis study aims to investigate the eligibility of the Prospective Comparison of Angiotensin Receptor–Neprilysin Inhibitor (ARNI) with ACE inhibitor to Determine Impact on Global Mortality and Morbidity in Heart Failure (PARADIGM‐HF) study to a real‐world heart failure population.Methods and resultsMedical records of all heart failure patients living within the catchment area of Umeå University Hospital were reviewed. This district consists of around 150 000 people. Out of 2029 patients with a diagnosis of heart failure, 1924 (95%) had at least one echocardiography performed, and 401 patients had an ejection fraction of ≤35% at their latest examination. The major PARADIGM‐HF criteria were applied, and 95 patients fulfilled all enrolment criteria and thus were eligible for sacubitril–valsartan. This corresponds to 5% of the overall heart failure population and 24% of the population with ejection fraction ≤ 35%. The eligible patients were significantly older (73.2 ± 10.3 vs. 63.8 ± 11.5 years), had higher blood pressure (128 ± 17 vs. 122 ± 15 mmHg), had higher heart rate (77 ± 17 vs. 72 ± 12 b.p.m.), and had more atrial fibrillation (51.6% vs. 36.2%) than did the PARADIGM‐HF population.ConclusionsOnly 24% of our real‐world heart failure and reduced ejection fraction population was eligible for sacubitril–valsartan, and the real‐world heart failure and reduced ejection fraction patients were significantly older than the PARADIGM‐HF population. The lack of data on a majority of the patients that we see in clinical practice is a real problem, and we are limited to extrapolation of results on a slightly different population. This is difficult to address, but perhaps registry‐based randomized clinical trials will help to solve this issue.

The reverse remodeling response to sacubitril/valsartan therapy in heart failure with reduced ejection fraction

“…Just as in the PARADIGM‐HF trial, the proportion of women in our cohort was low. This might be due to several reasons, for instance initiation of sacubitril/valsartan requires a reduced LVEF and toleration of a substantial dose of ACE‐I or ARB, which might be more likely to occur in men . Additionally, it is well known that women tend to exhibit a more pronounced reverse remodeling response following initiation of heart failure therapies including pharmacotherapy or CRT …”

“…This might be due to several reasons, for instance initiation of sacubitril/valsartan requires a reduced LVEF and toleration of a substantial dose of ACE-I or ARB, which might be more likely to occur in men. 25 Additionally, it is well known that women tend to exhibit a more pronounced reverse remodeling response following initiation of heart failure therapies including pharmacotherapy or CRT. 18 Although cardiologists should be convinced about the compelling benefit of sacubitril/valsartan based on the results of the PARADIGM-HF trial, prescription of sacubitril/valsartan remains rather low.…”

Evaluation of Patients with Heart Failure to Determine Eligibility for Treatment with Sacubitril/Valsartan: Insights from a Veterans Administration Healthcare System

“…We found that nearly one in three patients with HFrEF at the VAGLAHS was eligible for treatment with sacubitril/valsartan. It has been estimated that if the criteria from the PARADIGM‐HF trial are strictly followed, then sacubitril/valsartan should be prescribed to < 25% of patients with HFrEF . Researchers found that 12% of patients in a community HF clinic in the United Kingdom were eligible for sacubitril/valsartan treatment using the PARADIGM‐HF trial criteria .…”

“…Although patients eligible for treatment at VAGLAHS were more often elderly and had a higher NYHA functional classification compared with patients treated with sacubitril/valsartan in the PARADIGM‐HF trial, the similarities in most other characteristics suggest that this trial can be generalized to our cohort and that treating these eligible patients at VAGLAHS may also significantly reduce morbidity and mortality. A retrospective study that assessed the eligibility for sacubitril/valsartan in the Swedish population also found that their patients were generally older than those in the PARADIGM‐HF trial, which suggests that further studies in the elderly population may be beneficial …”

“…Several studies have hypothesized that the high cost, formulary restrictions, and adverse effect concerns associated with sacubitril/valsartan are significant reasons for the nationally reported underutilization of the medication . The non‐VA average wholesale price of sacubitril/valsartan is $6767.10 per patient annually .…”