Effects of sacubitril-valsartan in patients undergoing maintenance dialysis

Figures & data

Figure 1. Flow-chart of the recruitment of the patients.

Table 1. Baseline data of the sacubitril-valsartan (SV) group and control group patients.

	SV	Control	P
Number of patients	51	51
Gender (Female/Male)	16/35	16/35	1.0
Age (years) (median, IQR)	59 (51–69)	59 (51–68)	0.944
BMI (Kg/m^2) (median, IQR)	25.3 (22.6–27.7)	23.7 (22.2–26.4)	0.085
Dialysis modality (PD/HD)	32/19	32/19	1.0
Duration of dialysis (months) (median, IQR)	24.8 (15.0–48.5)	35.1 (16.3–57.3)	0.345
Hypertension, n (%)	51 (100%)	51 (100%)	1.0
Diabetes mellitus, n (%)	32 (62.7%)	25 (49%)	0.163
History of coronary disease, n (%)	31 (60.8%)	22 (43.1%)	0.074
History of heart infarctus, n (%)	17 (33.3%)	12 (23.5%)	0.272
Urine output (ml) (median, IQR)	500 (100–1000)	300 (0–800)	0.165
Causes of ESRD
Diabetes related kidney disease, n (%)	26 (51.0%)	26 (51.0%)	0.543
Glomerulonephritis, n (%)	11 (21.6%)	15 (29.4%)
Hypertensive nephropathy, n (%)	4 (7.8%)	4 (7.8%)
Polycystic kidney disease, n (%)	2 (3.9%)	3 (5.9%)
Others	8 (15.7%)	3 (5.9%)
Laboratory indices
Cholesterol, mmol/L (median, IQR)	3.59 (3.06–4.23)	3.83 (3.09–4.31)	0.497
LDL-C, mmol/L (median, IQR)	1.73 (1.41–2.48)	1.98 (1.54–2.29)	0.886
HDL-C, mmol/L (median, IQR)	0.95 (0.73–1.16)	0.88 (0.78–1.11)	0.870
Calcium, mmol/L (median, IQR)	2.25 (2.13–2.36)	2.23 (2.1–2.35)	0.933
Phosphorus, mmol/L (median, IQR)	1.48 (1.24–1.90)	1.62 (1.31–1.99)	0.124
PTH, pg/ml (median, IQR)	173.9 (88.1–280.0)	197.7 (125.5–384.6)	0.119
HbA1c, % (median, IQR)	6.3 (5.4–7.3)	6.3 (5.5–7.2)	0.542
Other medications
ACEI/ARB	44 (86.3%)*	46 (90.2%)	0.539
CCB	43 (84.3%)	30 (58.8%)	0.004
β-blocker	31 (60.8%)	27 (52.9%)	0.424
α-blocker	18 (35.3%)	11 (21.6%)	0.124
Diuretics	40 (78.4%)	32 (62.7%)	0.082

Note: *ACEI/ARB treatment before the initiation of SV. SV: sacubitril-valsartan; BMI: body mass index; PD: peritoneal dialysis; HD: hemodialysis; ESRD: end-stage renal disease; ACEI: angiotensin converting enzyme inhibitor; ARB: angiotensin receptor blocker; CCB: calcium channel blocker; IQR: interquartile range.

Figure 2. Levels of BNP or NT-proBNP before and after sacubitril-valsartan (SV) introduction in SV group. BNP, B-type natriuretic peptide; NT-proBNP, pro-B-type natriuretic peptide; PD, peritoneal dialysis; HD, hemodialysis.

Table 2. Comparison of echocardiography parameters between SV and control group.

	SV group baseline (51 patients)	SV group follow-up (51patients)	Variant rate of SVgroup (%)	P*	Control group baseline (51 patients)	Control group follow-up (51 patients)	Variant rate of control group (%)	P**	P***
LVEF, %	61.5 (58.0–66.3)	62.0 (58.8–68.3)	2.2 (−4.6 − 8.7)	0.136	65.0 (58.8–68.0)	62.5 (60.0–68.0)	−3.01 (−7.7 − 5.1)	0.139	0.033
LVEDd, mm	51.0 (46.8–56.3)	50.0 (47.0–54.5)	0 (−7.8 − 6.3)	0.641	49.5 (46.0–53.0)	48.5 (44.8–52.3)	–2.0 (−8.5 − 2.5)	0.340	0.204
LAd, mm	44.0 (40.0–48.3)	43.0 (39.0–48.0)	–2.4 (−8.6 − 5.7)	0.296	39.5 (37.5–46.0)	40.5 (37.0–43.0)	–2.3 (−10.9 − 7.6)	0.084	0.704
RVDd, mm	37.0 (31.0-38.0)	34.0 (30.0–40.0)	0 (−8.8–7.9)	0.818	34.0 (31.0–38.0)	32.0 (30.0–37.0)	−3.2 (−7.7 − 5.6)	0.305	0.628
RAd, mm	38.0 (32.0–42.0)	36.0 (32.8–40.5)	−1.1 (−7.1 − 9.2)	0.656	34.5 (32.0–39.8)	35.5 (31.0–37.8)	−7.6 (−12.4–11.8)	0.353	0.312
IVSd, mm	11.0 (10.0–13.1)	11.0 (10.0–13.0)	0 (−4.3 − 7.4)	0.677	11.0 (9.0–12.0)	11.0 (10.0–12.0)	0 (−8.3 − 9.3)	0.803	0.625

Note: Baseline and follow-up data of LVEF, LVEDd, LAd and IVSd were available in 50 patients of the SV group and 50 patients of the control group. Baseline and follow-up data of RVDd and RAd were available in 30 patients of the SV group and 28 patients of the control group. SV: sacubitril-valsartan; LVEF: left ventricular ejection fraction; LVEDd: left ventricular end-diastolic diameter; LAd: left atrium diameter; RVDd: right ventricular diastolic diameter; RAd: right atrium diameter; IVSd: interventricular septum diastolic thickness. Data were expressed as median (interquartile range). P* represented comparison between baseline and follow-up data in the SV group. P** represented comparison between baseline and follow-up data in the control group. P*** represented comparison between variant rate of SV group and of control group.

Table 3. Comparison of echocardiography parameters between PD patients and the control group.

	PD group baseline (32 patients)	PD group follow-up (32 patients)	Variant rate of PD group (%)	P*	Control group baseline (32 patients)	Control group follow-up (32 patients)	Variant rate of control group (%)	P**	P***
LVEF, %	61.0 (58.3–66.8)	62.5 (59.3–69.8)	4.4 (−2.8 − 9.4)	0.007	65.0 (59.0–69.0)	61.0 (60.0–67.0)	−4.8 (−10.0 − 5.8)	0.141	0.004
LVEDd, mm	51.0 (47.5–56.8)	50.0 (47.0–55.5)	−-0.9 (−8.1 − 4.0)	0.110	50.0 (45.0-53.0)	49.0 (44.0-52.0)	−2.0 (−11.1 − 2.0)	0.390	0.630
LAd, mm	45.0 (43.3–49.8)	44.0 (40.0–48.00)	−4.1 (−9.0 − 4.4)	0.095	41.0 (38.0–46.0)	41.0 (37.0–44.0)	−4.4 (−12.2 − 7.7)	0.089	0.837
RVDd, mm	37.5 (31.8–39.3)	34.0 (30.8–40.3)	−2.4 (−8.2 − 5.4)	0.321	35.0 (31.8–38.3)	33.0 (30.0–38.0)	−5.6 (−10.0 − 9.0)	0.433	0.975
RAd, mm	38.5 (32.8-44.0)	35.5 (32.8–42.0)	−2.5 (−7.1 − 4.6)	0.242	36.0 (32.0–40.0)	36.0 (31.0–38.0)	−7.5 (−12.5–12.5)	0.455	0.693
IVSd, mm	11.9 (10.1–13.9)	11.4 (10.9–13.0)	0 (−5.3 − 5.0)	0.716	11.0 (10.0–12.0)	11.0 (10.0–12.0)	−3.0 (−9.1 − 9.1)	0.114	0.258

Note: Baseline and follow-up data of LVEF, LVEDd, LAd and IVSd were available in 32 patients of the SV group and 31 patients of the control group. Baseline and follow-up data of RVDd and RAd were available in 18 patients of the SV group and 18 patients of the control group. SV:sacubitril-valsartan; LVEF: left ventricular ejection fraction; LVEDd: left ventricular end-diastolic diameter; LAd: left atrium diameter; RVDd: right ventricular diastolic diameter; Rad: right atrium diameter; IVSd: interventricular septum diastolic thickness. Data were expressed as median (interquartile range). P* represented comparison between baseline and follow-up data in the PD group. P** represented comparison between baseline and follow-up data in the control group. P*** represented comparison between variant rate of PD group and of control group.

Table 4. Fluid statue and urine of SV and control group.

	SV group baseline	SV group follow-up	variant rate (%)	P*	Control baseline	Control folllow-up	variant rate (%)	P**	P***
Kt/V	1.61 (1.42–1.99)	1.67 (1.42–1.96)	1.37 (–11.99–16.84)	0.731	1.60 (1.44–1.79)	1.63 (1.40–1.91)	2.40 (−8.94–12.93)	0.429	0.831
OH, L	3.90 (2.33–7.15)	3.55 (2.13–5.93)	−13.13 (−42.85–27.84)	0.157	2.50 (1.6–3.9)	3.00 (2.00-–.80)	0.00 (–17.95–53.85)	0.660	0.049
Relative OH (%)	21.65 (13.85–33.98)	19.25 (11.63–28.85)	−11.07 (−39.03–13.13)	0.092	13.80 (9.90–22.50)	17.00 (11.90–22.40)	2.02 (−12.29–47.11)	0.515	0.021
Urine, ml	500 (100–1000)	150 (0–700)	−21.43 (–60.0–0)	0.003	300 (0–800)	160 (0–500)	0 (−37.5–0)	<0.001	0.652

Note: SV: sacubitril-valsartan; OH: overhydration parameter. Data were expressed as median (interquartile range). P* represented comparison between baseline follow-up data in the SV group. P** represented comparison between baseline and follow-up data in the control group. P*** represented comparison between variant rate of SV group and of control group.

Figure 3. Baseline and follow-up data of blood pressure and heart rate in the SV group and control group. SBP, systolic blood pressure; DBP, diastolic blood pressure; HR, heart rate.

Figure 4. Kaplan-Meier curve of the composite endpoints events in the SV group and the control group.