ARNI use safe and effective in elderly HFrEF patients
Sacubitril/Valsartan is useful and safe in elderly people with heart failure and reduced ejection fraction. Data from a real-word cohort
Introduction and methods
Prevalence of HF increases with age [1-4]. However, in clinical HF trials elderly patients are underrepresented as the mean age lies below 65 years [5,6]. HF medication with impact on survival are less frequently used in the elderly population due to a lack of evidence, more adverse effects, higher prevalence of comorbidities and lower adherence [7-9]. The PARADIGM-HF study showed that Sacubitril/Valsartan (S/V) reduced the risk of CV mortality and HF hospitalization in symptomatic HFrEF patients . A sub-analysis with patients over 65 years of age showed that this population also benefits from treatment with S/V with similar safety . However, due to lower incidence of the primary outcome in elderly patients compared to other trials and restricted inclusion criteria in PARADIGM-HF, an evaluation of S/V in real-world cohort of elderly patients was desired.
This study performed a prospective registry of elderly HFrEF patients who started S/V in clinical practice in 10 hospitals of Madrid Autonomic Community. 427 Patients were enrolled, with a mean age of 68.1 ± 12.4 years. 222 (52.0%) Were <70 years of age, 140 (32.8%) were between 70 and 79 years and 65 (15.2%) were ≥80 years. The mean follow-up was 7.0 ± 0.1 months. Occurrence of events (death, emergency room visits and hospitalization), S/V adverse effects, clinical characteristics, and maximum tolerated dose and drug withdrawal were analyzed.
- No differences in prevalence of adverse effects were observed in the three different age groups; <70 years, 70-79, and ≥80 (25.2%, 25.7%, 23.1% respectively; P=0.835). Among adverse effects, symptomatic hypotension was the most frequently reported.
- Higher doses at the end of follow-up were achieved in younger patients. In the youngest age group 46.3% received 97/103 mg b.d. and 19.5% received the lowest dose of 24/26 mg b.d. In the oldest age group, only 16.9% achieved a dose of 97/103 mg b.d. at the end of follow-up, while 36.9% received a dose of 24/26 mg b.d..
- The withdrawal rate of S/V decreased with increasing age group (14.4%, 10.0%, 4.6% respectively; p = 0.05) and was related to poor prognosis (HR 13.51, 95% CI 3.22–56.13, P< 0.001).
- NYHA class improved with S/V use and NYHA class improvement increased with increasing age group (66.2%, 83.6% and 93.9%, respectively; P<0.01).
This prospective registry study of real-world data of elderly HFrEF patients who received S/V, suggests that S/V is safe and effective in elderly patients. No age-related differences were found in the prevalence of adverse events. More older patients (≥ 80 years) achieved a lower dose compared to younger patients (<70 years).