Key result
Valsartan/cilnidipine did not significantly suppress home morning blood pressure surge compared with valsartan/hydrochlorothiazide (14.4 vs 14.0 mm Hg; P=0.892).
Why the study?
Does a valsartan/cilnidipine combination reduce home morning blood pressure surge more effectively than a valsartan/hydrochlorothiazide combination in patients with morning hypertension?
RCT (n=129)
Open-label
randomized
Yes
Does a valsartan/cilnidipine combination reduce home morning blood pressure surge more effectively than a valsartan/hydrochlorothiazide combination in patients with morning hypertension?
A valsartan/cilnidipine combination does not significantly suppress home morning blood pressure surge compared with a valsartan/hydrochlorothiazide combination in patients with morning hypertension.
Neither combination superiorly suppresses morning surge; confirms comparable efficacy of cilnidipine versus hydrochlorothiazide add-on to valsartan.
The authors tested the hypothesis that a valsartan/cilnidipine combination would suppress the home morning blood pressure (BP) surge (HMBPS) more effectively than a valsartan/hydrochlorothiazide combination in patients with morning hypertension, defined as systolic BP (SBP) ≥135 mm Hg or diastolic BP ≥85 mm Hg assessed by a self-measuring information and communication technology-based home BP monitoring device more than three times before either combination's administration. This was an 8-week prospective, multicenter, randomized, open-label clinical trial. The HMBPS, which is a new index, was defined as the mean morning SBP minus the mean nocturnal SBP, both measured on the same day. The authors randomly allocated 129 patients to the valsartan/cilnidipine (63 patients; mean 68.4 years) or valsartan/hydrochlorothiazide (66 patients; mean 67.3 years) combination groups, and the baseline HMBPS values were 17.4 mm Hg vs 16.9 mm Hg, respectively (P = .820). At the end of the treatment period, the changes in nocturnal SBP and morning SBP from baseline were significant in both the valsartan/cilnidipine and valsartan/hydrochlorothiazide groups (P < .001): -5.0 vs -10.0 mm Hg (P = .035) and -10.7 vs -13.6 mm Hg (P = .142), respectively. HMBPS was significantly decreased from baseline in both groups (P < .001), but there was no significant difference between the two groups: 14.4 mm Hg vs 14.0 mm Hg, respectively (P = .892). Valsartan/cilnidipine could not significantly suppress HMBPS compared with valsartan/hydrochlorothiazide. Large-scale randomized controlled studies are needed to assess how reducing HMBPS will affect future cardiovascular outcomes. The information and communication technology-based home BP monitoring device may become an alternative to ambulatory BP monitoring, which has been a gold standard to measure nocturnal BP and the morning BP surge.
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Fujiwara et al. (2018) conducted an RCT in Morning hypertension (n=129). Valsartan/cilnidipine vs. Valsartan/hydrochlorothiazide was evaluated on Home morning blood pressure surge (HMBPS) (p=.892). Valsartan/cilnidipine did not significantly suppress home morning blood pressure surge compared with valsartan/hydrochlorothiazide (14.4 vs 14.0 mm Hg; P=0.892).
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