Comparison of morning vs bedtime administration of the combination of valsartan/amlodipine on nocturnal brachial and central blood pressure in patients with hypertension

Abstract

The aim of this study was to compare the effect of morning and bedtime administration of valsartan/amlodipine combination therapy (80/5 mg) on nocturnal brachial and central blood pressure (BP) measured by ambulatory BP monitoring in patients with hypertension. This was a 16-week prospective, multicenter, randomized, open-label, crossover, noninferiority clinical trial. Patients underwent 24-hour ambulatory BP monitoring at randomization, at switching, and at the end of the study. Twenty-three patients (mean age, 68.0 years) were studied. The difference in nocturnal brachial systolic BP between the morning and bedtime administrations of combination valsartan/amlodipine was -3.2 mm Hg, and the two-sided 95% confidence interval ranged from -6.8 to 0.4 mm Hg. The difference in nocturnal central systolic BP was -4.0 mm Hg (95% confidence interval, -7.6 to -0.4 mm Hg). The upper limit of the 95% confidence interval was below the margin of 3.0 mm Hg in both nocturnal brachial and central systolic BP, confirming the noninferiority of morning administration to the bedtime administration of valsartan/amlodipine combination therapy.

Keywords: amlodipine; bedtime administration; clinical trial; crossover; morning administration; nocturnal central blood pressure; noninferiority; valsartan.

Conflict of interest statement

The authors have no potential conflicts of interest to declare.

©2017 Wiley Periodicals, Inc.

Figures

Figure 1

Design of the study. ABPM indicates ambulatory blood pressure monitoring; ARB, angiotensin II receptor blocker; BP, blood pressure; CCB, calcium channel blocker; DBP, diastolic blood pressure; SBP, systolic blood pressure

Figure 2

Patients' disposition

Figure 3

Comparison of nocturnal blood pressure levels in the individual patient at each administration period. DBP indicates diastolic blood pressure; SBP, systolic blood pressure

Figure 4

(A) The 95% confidence interval (CI) of the difference between the morning and bedtime administrations in the changes of nocturnal brachial and central systolic blood pressure (SBP) from baseline. aAdjusted for the change of nocturnal heart rate. (B) The 95% CI of the difference between the morning and bedtime administrations in the changes of nocturnal brachial and central diastolic blood pressure (DBP) from baseline. aAdjusted for the change of nocturnal heart rate. SEM indicates standard error of the mean