What is the clinical evidence from this study?

Study design: RCT. Population: Mild-to-moderate essential hypertension (n=418). Intervention: Verapamil + Low-salt diet vs. Verapamil + unrestricted-salt diet (High-salt group). Primary outcome: Achievement of therapeutic goal (DBP < 90 mmHg).

June 1, 1993

Antihypertensive activity of verapamil: impact of dietary sodium

Q: What are the key findings of this study?

Dietary sodium restriction did not have an additive effect on the antihypertensive efficacy of verapamil, with therapeutic goals achieved in 38.3% of low-salt vs 44.8% of high-salt patients.

Key Result

Dietary sodium restriction did not have an additive effect on the antihypertensive efficacy of verapamil, with therapeutic goals achieved in 38.3% of low-salt vs 44.8% of high-salt patients.

Study Design

Type

RCT (n=418)

Randomization

Parallel

Multicenter

Yes

Structured PICO

Does a low-salt diet improve the antihypertensive effect of verapamil in patients with mild-to-moderate essential hypertension?

Population

418 patients with mild-to-moderate essential hypertension (DBP 90-114 mmHg) who achieved 24-h urinary sodium excretion ≤ 120 mmol/day after a 2-week low-salt run-in period.

Intervention

Slow-release verapamil 240 mg once daily combined with a moderately low salt diet (target UNa ≤ 120 mmol/day) for 28 days.

Comparator

Slow-release verapamil 240 mg once daily combined with an unrestricted-salt diet (target UNa > 120 mmol/day) for 28 days.

Outcome

Reduction in mean systolic and diastolic blood pressure, and achievement of therapeutic goal (DBP < 90 mmHg).surrogate

Dietary sodium restriction does not enhance the antihypertensive efficacy of the calcium channel blocker verapamil in patients with mild-to-moderate essential hypertension.

Main Result

Absolute Event Rate: 38.3% vs 44.8%

Abstract

OBJECTIVE: To define the influence of dietary salt intake on the antihypertensive effect of slow-release verapamil 240 mg once a day in a population with mild-to-moderate essential hypertension. DESIGN: Parallel, randomized, multicentre study. METHODS: Patients were advised to follow a moderately low salt diet (Low-salt group). After a 2-week run-in period, those patients with 24-h urinary sodium excretion (UNa) 120 mmol/day with UNa increased by > or = 60 mmol/day over the level attained at the end of the run-in period. RESULTS: Significant reductions in mean systolic blood pressure (SBP) and DBP were found in both the Low-salt (n = 235) and High-salt (n = 183) groups. The therapeutic goal (DBP < 90 mmHg) was achieved in 38.3% of patients in the Low-salt and 44.8% of patients in the High-salt group. Office blood pressure results were confirmed by ambulatory 24-h blood pressure monitoring in a subsample of patients. Verapamil reduced mean blood pressure throughout the nycthemeral cycle without any significant difference between the two groups. CONCLUSION: The restriction in sodium intake does not have an additive effect on the antihypertensive effect of the slow-channel calcium antagonist verapamil.

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