Key result
Morning administration of valsartan/amlodipine was noninferior to bedtime administration for nocturnal brachial systolic BP (difference -3.2 mm Hg; 95% CI -6.8 to 0.4) and central systolic BP.
Why the study?
Does morning administration of valsartan/amlodipine improve nocturnal brachial and central blood pressure compared to bedtime administration in patients with hypertension?
RCT (n=23)
Open-label
crossover
Yes
Does morning administration of valsartan/amlodipine improve nocturnal brachial and central blood pressure compared to bedtime administration in patients with hypertension?
Mean Difference: -3.2 (95% CI -6.8–0.4)
Morning administration of valsartan/amlodipine is noninferior to bedtime administration for controlling nocturnal brachial and central blood pressure in hypertensive patients.
Noninferiority of morning to bedtime dosing confirmed for nocturnal brachial/central SBP; extends chronotherapy data but leaves outcome impact open.
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.
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Fujiwara et al. (2017) conducted an RCT in hypertension (n=23). Morning administration of valsartan/amlodipine vs. Bedtime administration of valsartan/amlodipine was evaluated on nocturnal brachial systolic BP (MD -3.2 mm Hg, 95% CI -6.8 to 0.4). Morning administration of valsartan/amlodipine was noninferior to bedtime administration for nocturnal brachial systolic BP (difference -3.2 mm Hg; 95% CI -6.8 to 0.4) and central systolic BP.
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