https://orcid.org/0000-0002-0660-5372
Abstract
BACKGROUND
We investigated the effects of sacubitril/valsartan, a first-in-class angiotensin receptor neprilysin inhibitor (ARNI), on 24-hour blood pressure (BP) and safety for 12 weeks in Japanese patients with non-dialysis advanced chronic kidney disease (CKD).
METHODS
We conducted a prospective, single-arm exploratory study. Patients with non-dialysis CKD stage G4-5 (estimated glomerular filtration (eGFR) <30 mL/min/1.73 m2) who did not achieve their BP goals with angiotensin receptor blocker (ARB) administration, were enrolled and switched to sacubitril/valsartan. Primary and key secondary endpoints were changes from baseline in the 24-hour systolic BP (SBP) measured via ambulatory BP monitoring (ABPM) over 12 weeks and the safety, especially incidence of serum creatinine (Cr) increase (≥ 30% increase from baseline) and hyperkalemia.
RESULTS
Thirty patients were enrolled, and 29 patients were switched to sacubitril/valsartan. Efficacy analysis was conducted on 26 patients. Baseline mean eGFR and office BP were 21.1 ± 5.0 mL/min/1.73m2 and 149.4 ± 23.7/80.7 ± 11.9 mmHg, respectively. Baseline 24-hour, daytime, and nighttime BP were 139.6 ± 17.7/77.0 ± 7.8 mmHg, 143.5 ± 18.5/79.6 ± 8.7 mmHg, and 131.0 ± 20.4/71.1 ± 8.8 mmHg, respectively. After 12 weeks, changes in 24-hour, daytime, and nighttime SBP from baseline were -7.1 ± 12.4 mmHg (P < 0.01), -7.7 ± 12.9 mmHg (P < 0.01), and -5.8 ± 15.8 mmHg (P = 0.07), respectively. No incidences of potassium values > 6.0 mmol/L or serum Cr ≥ 30% increase from baseline were reported after sacubitril/valsartan initiation.
CONCLUSIONS
Switching from ARB to sacubitril/valsartan can safely enhance 24-hour antihypertensive treatment in patients with non-dialysis CKD G4-5 who do not achieve BP goals with ARBs. CLINICAL TRIALS REGISTRATION: Trial Number jRCT1031220149.
CLINICAL TRIALS REGISTRATION
Trial Number jRCT1031220149.
