What is the clinical evidence from this study?

Study design: RCT. Population: Uncontrolled hypertension (n=150). Intervention: Valsartan/amlodipine vs. Nifedipine GITS 30 mg once daily. Primary outcome: Change in 24-hour ambulatory systolic blood pressure from baseline to 12 weeks (MD -2.1 mm Hg, 95% CI -5.9, 1.6, p=0.26).

December 24, 2018Open Access

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

Key Result

Valsartan/amlodipine 80/5 mg reduced nighttime systolic blood pressure more effectively than nifedipine GITS 30 mg in non-dippers (between-group difference -6.5 mm Hg, P=0.02) and improved arterial stiffness independent of blood pressure lowering.

Study Design

Type

RCT (n=150)

Blinding

Open-label

Randomization

Central randomization scheme

Multicenter

Yes

Structured PICO

Does valsartan/amlodipine single-pill combination improve ambulatory blood pressure and arterial stiffness compared to nifedipine GITS in patients with uncontrolled hypertension?

Population

150 adults aged 18-65 years with uncontrolled hypertension after monotherapy, followed for 12 weeks.

Intervention

Valsartan/amlodipine 80/5 mg single-pill combination oral once daily in the morning for 12 weeks.

Comparator

Nifedipine GITS 30 mg oral once daily in the morning for 12 weeks.

Outcome

Ambulatory blood pressure (24-hour, daytime, and nighttime) and arterial stiffness assessed by brachial-ankle pulse wave velocity (PWV) at 12 weeks.surrogate

Valsartan/amlodipine single-pill combination is more effective than nifedipine GITS in lowering nighttime blood pressure and arterial stiffness in patients with uncontrolled hypertension.

Main Result

Mean Difference: -2.1 (95% CI -5.9–1.6)

Absolute Event Rate: -4.8% vs -2.7%

p-value: p=0.26

Limitations

Subgroup analysis of a randomized controlled trial without specific sample size estimation
Potential selection bias due to restriction to sites with specific measurement devices and high baseline use of calcium-channel blockers
Relatively small sample size and short follow-up time
High proportion of white-coat uncontrolled hypertension may have diminished the between-treatment differences in ambulatory blood pressure in the overall study population

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.

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