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Safety profile of sacubitril-valsartan in heart failure with reduced ejection fraction with chronic kidney disease, a real life study
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A Recio Mayoral1
FJ Cortes Cortes1
P Caravaca Perez1
DF Arroyo Monino1
M Ribadeneira Ruiz1
MP Ruiz Garcia1
M Chaparro Munoz1
A Castro Fernandez1
1Virgen Macarena University Hospital - Seville - Spain
Topic(s): Chronic Heart Failure: Pharmacotherapy
Sacubitril/valsartan (S/V) has shown to decrease the risk of cardiovascular mortality in heart failure with reduced ejection fraction (HFrEF) patients and might be a promising therapeutic approach in patients with renal dysfunction. However, its effects in patients with associatedchronic kidney disease(CKD) is unknown, as there is no evidence to support any recommendation.
Weaimed to evaluate the tolerability and safety profile of S/V in advanced CKD patients with HFrEF.
This study was performed as a prospective, single-center descriptive study from January 2016-January 2018.By using baseline estimated glomerular filtration rate (GFR), patients were stratified in 2 groups, without and with CKD (<60 ml/min/1.73 m2). Patients were evaluated monthly during the first 3 months and in month 6 and 12 after initiated S/V. The safety pre-specified primary end-point was the composite of angioedema, symptomatic hypotension, renal impairment and hyperkaliemia.
Of the 336 consecutive HFrEF patients included (69±11 years, female (87; 25.9%)in whom were initiated S/V,131 had CKD (stage 3, 112 patients, 33.3%; stage 4, 19 patients, 5.7%).More than half of the patients (54,8%) suffered from ischemic cardiomyopathy with a mean left ventricular ejection fraction of 30.5±6.8%. The majority, 51.8%, were on NYHA functional class II (NYHA III 37.3%; IV 4.5%).
No significant differences were found in S/V dose achieved and remained between patients without and with CKD (low dose, 20.4 vs 26.4%; medium dose 28.2 vs 35.2% and highest dose 48.6 vs 34.1%, respectively). At 1 year follow up, the combined primary end-point was numerically higher in patients with CKD compared with those patients without, although did not reach significant difference (14.4 vs 21.8, p=0.1): angioedema (1 vs 0.8%, p=0.52), symptomatic hypotension (7.9 vs 14.3%, p=0.18), severe renal impairment (0 vs 4.5%, p=0.07) and potassium =5.5 mmol/L (8.4 vs 16.7%, p=0.06). In 9 patients was necessary discontinue S/V, 4 without CKD and 5 with.
In both subgroups of patients, no significant changes were found in mean GFR during follow up.
CONCLUSIONS: CKD could be an acceptable treatment to reduce cardiovascular risk in HFrEF patients with CKD, with a good tolerability and safety profile