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Randomized Controlled Trial
. 2019 Feb;21(2):252-261.
doi: 10.1111/jch.13457. Epub 2018 Dec 24.

A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS

Shao-Kun Xu  1 , Qi-Fang Huang  1 , Wei-Fang Zeng  1 , Chang-Sheng Sheng  1 , Yan Li  1 , Ji-Guang Wang  1
Affiliations
Randomized Controlled Trial

A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS

Shao-Kun Xu et al. J Clin Hypertens (Greenwich). 2019 Feb.

Abstract

In a pre-specified subgroup analysis of a 12-week randomized multicenter study, we investigated effects of valsartan/amlodipine 80/5 mg single-pill combination (n = 75) and nifedipine GITS 30 mg (n = 75) on ambulatory blood pressure (BP) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV) in patients with uncontrolled hypertension. At week 12, the between-treatment mean differences in systolic/diastolic BP were smaller for 24-hour and daytime (-2.1/-1.7 and -2.0/-1.5 mm Hg, respectively, P ≥ 0.22) but greater (P < 0.01) for nighttime (-4.0/-2.8 mm Hg, P ≤ 0.09), especially in sustained uncontrolled hypertension (-5.0/-4.1 mm Hg, P ≤ 0.04) and non-dippers (-6.5/-3.7 mm Hg, P ≤ 0.07), in favor of valsartan/amlodipine. At week 12, PWV was significantly reduced from baseline by valsartan/amlodipine (n = 59, P < 0.0001) but not nifedipine (n = 59, P = 0.06). The changes in PWV were significantly associated with that in ambulatory systolic BP and pulse pressure in the nifedipine (P ≤ 0.0008) but not valsartan/amlodipine group (P ≥ 0.57), with a significant interaction (P ≤ 0.045). The valsartan/amlodipine combination was more efficacious than nifedipine GITS in lowering nighttime BP in sustained uncontrolled hypertension and non-dippers, and in lowering arterial stiffness independent of BP lowering.

Keywords: ambulatory blood pressure; amlodipine; arterial stiffness; single-pill combination; valsartan.

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Conflict of interest statement

Ji‐Guang Wang was financially supported by grants from the National Natural Science Foundation of China (grants 81170245 and 91639203), Beijing, China and the Shanghai Commissions of Science and Technology (grant 15XD1503200) and Health and Family Planning (grant 15GWZK0802 and a special grant for “Leading Academics”), Shanghai, China, and reports receiving lecture and consulting fees from Astra‐Zeneca, Bayer, Daiichi‐Sankyo, Novartis, Omron, Pfizer, Sanofi, Servier, and Takeda. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
24‐h blood pressure profile at baseline (circle) and 12 weeks of treatment (dot) with the valsartan/amlodipine 80/5 mg single‐pill combination or nifedipine GITS 30 mg. Symbols denote hourly mean. Vertical lines denote standard error
Figure 2
Figure 2
Changes in brachial‐ankle pulse wave velocity from baseline (circle) to 12 weeks of treatment (dot). Mean values are given alongside with standard deviation (vertical line). The least square mean change ± standard error and P values were adjusted for sex and the baseline age, body mass index, mean arterial pressure, pulse rate, and brachial‐ankle pulse wave velocity, and are given for each randomized group above the graph
Figure 3
Figure 3
Scatter plot for the interrelationship of the changes in brachial‐ankle pulse wave velocity with the changes in ambulatory systolic blood pressure (left panel) and pulse pressure (right panel). Regression lines were drawn for the valsartan/amlodipine 80/5 mg combination group (dot) and the nifedipine GITS 30 mg group (circle) separately. Pearson correlation r values and P values are given for the regression line of the nifedipine GITS group (P) and for the interaction between randomized treatment and the changes in ambulatory systolic blood pressure or pulse pressure in relation to the changes in brachial‐ankle pulse wave velocity (P int)
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References

    1. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the american college of cardiology/american heart association task force on clinical practice guidelines. Hypertension. 2018;71:1269‐1324. - PubMed
    1. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: the task force for the management of arterial hypertension of the European Society of Cardiology and the European Society of Hypertension. J Hypertens. 2018;36:1953‐2041. - PubMed
    1. Machnicki G, Ong SH, Chen W, Wei ZJ, Kahler KH. Comparison of amlodipine/valsartan/hydrochlorothiazide single pill combination and free combination: adherence, persistence, healthcare utilization and costs. Curr Med Res Opin. 2015;31:2287‐2296. - PubMed
    1. Kawalec P, Holko P, Stawowczyk E, Borowiec Ł, Filipiak KJ. Economic evaluation of single‐pill combination of indapamide and amlodipine in the treatment of arterial hypertension in the Polish setting. Kardiol Pol. 2015;73:768‐780. - PubMed
    1. Fleig SV, Weger B, Haller H, Limbourg FP. Effectiveness of a fixed‐dose, single‐pill combination of perindopril and amlodipine in patients with hypertension: a non‐interventional study. Adv Ther. 2018;35:353‐366. - PMC - PubMed

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