Safety of Sacubitril/Valsartan in Geriatric Heart Failure Patients: An Observational Study

Introduction: The safety of sacubitril/valsartan is not well known in geriatric patients as they are not well represented in clinical trials. Materials and Methods: This was a single-center, retrospective, observational study of geriatric heart failure (HF) patients who are 65 years or older with reduced left ventricular ejection fraction ≤ 40% treated with an angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blockers (ARBs), or angiotensin receptor/neprilysin inhibitors (ARNIs). Eight hundred patients diagnosed with HF were screened from 2019 to 2020, and 300 patients were 65 years or older, of whom 176 patients met the inclusion criteria. The primary endpoint was the composite rate of adverse events, including renal injury, hyperkalemia, hypotension, and cough related to ARNI compared with ACEi and ARBs. Results: A total of 176 patients were enrolled: 96 patients were in the ARNI group and 80 patients were in the ACEi/ARBs group. The study population comprised 126 male patients and 50 female patients without significant difference between ACEi/ARBs and the sacubitril/valsartan group. The mean age was 71.6 ± 5.2 years in the sacubitril/valsartan group and 73.8 ± 7.1 years in the ACEi/ARBs group ( P value 0.02). There was a significant difference between ARNI and ACEi/ARBs groups on MRA use, as ARNI had lower use of MRA compared with the ACEi group ( P value 0.03). The number of adverse events occurred in 36 patients: 22 patients in the ARNI group and 14 patients in the ACEi/ARBs group. The most common adverse events was hyperkalemia, which was recorded in 11 patients, eight patients with hypotension, and two ARNI patients who had renal injury. Six patients in the ARNI group had adverse events that led to discontinuation, three patients were switched to ACEi or ARBs, and 10 patients required dose reduction. Other two patients continued the same dose with close monitoring and one lost to follow-up. In the ACEi/ARBs group, a total of fourteen patients experienced events, eight of them had to discontinue therapy, two required a dose reduction, three were switched to ARBs, and one to ACEi. Conclusion: ARNI can be safely used in the geriatric population as the rate of adverse events is not significantly different from ACEi and ARBs.