Twenty-Four-Hour Blood Pressure-Lowering Efficacy of Sacubitril/Valsartan Versus Olmesartan in Japanese Patients With Essential Hypertension Based on Nocturnal Blood Pressure Dipping Status: A Post Hoc Analysis of Data From a Randomized, Double-Blind Multicenter Study

BACKGROUND: Nighttime blood pressure (BP) and an abnormal nocturnal BP dipping profile are important cardiovascular risk factors in patients with hypertension. This post hoc analysis investigated the effects of sacubitril/valsartan on 24-hour BP in patients with mild-to-moderate hypertension and in patient subgroups based on nocturnal BP dipping status. METHODS AND RESULTS: Data from a randomized clinical trial comparing the BP-lowering effects of 8 weeks of treatment with sacubitril/valsartan (200 or 400 mg/d) and olmesartan (20 mg/d) in Japanese patients with mild-to-moderate hypertension were analyzed. The primary end point was change in 24-hour, daytime, and nighttime BP in patient subgroups based on nocturnal BP dipping status (dipper, nondipper). Six hundred thirty-two patients with baseline and follow-up ambulatory BP data were included. Both sacubitril/valsartan dosages reduced 24-hour, daytime, and nighttime systolic BP, and 24-hour and daytime diastolic BP, to a significantly greater extent than olmesartan in the dipper and nondipper groups. However, between-group differences in nighttime systolic BP were more significant in the nondipper group (difference [95% CI] for sacubitril/valsartan 200 and 400 mg/d versus olmesartan 20 mg/d: -4.6 [95% CI, -7.3 to -1.8] and -6.8 [95% CI, -9.5 to -4.1] mm Hg, respectively; P<0.01 and P<0.001). Between-group differences in the BP control rate were greatest in the nondipper subgroup (systolic BP control rate of 34.4% and 42.6% with sacubitril/valsartan 200 and 400 mg/d versus 23.1% with olmesartan 20 mg/d). CONCLUSIONS: This analysis highlights the value of sacubitril/valsartan therapy in patients with a nondipper profile of nocturnal BP and confirms this agent's potent 24-hour BP-lowering effect in Japanese populations with hypertension. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01599104.