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.