What is the clinical evidence from this study?

Study design: RCT. Population: Hypertension (n=187). Intervention: Isradipine vs. Placebo. Primary outcome: Rate of normalization (diastolic blood pressure ≤ 90 mm Hg) (p=.003).

What question did this study set out to answer?

To compare the blood pressure-lowering effects of isradipine against placebo at the end of a 12-hour dosing interval.

February 1, 1991American Journal of Hypertension

Isradipine Twice Daily Lowers Blood Pressure Over 24 H

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Key result

Isradipine 2.5 mg twice daily significantly increased the rate of diastolic blood pressure normalization compared to placebo (54% vs 33%; P=.003).

Why the study?

Does isradipine 2.5 mg twice daily improve blood pressure normalization at trough compared to placebo in patients previously responsive to isradipine?

Population

187 patients who had previously shown a response to treatment with isradipine based on office blood pressure…

Comparison

Isradipine 2.5 mg twice daily for six weeks vs Placebo for six weeks

Design

RCT, randomized, double-blind

Follow-up

6 weeks

Authors

AVA. J. Man inʼt VeldRotterdam University of Applied Sciences HGHolmes David G.Sanden (Japan)ALA LasanceSanden (Japan)

Discussion

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Implication

Supports isradipine 2.5 mg BID for sustained trough BP control; confirms efficacy in previously responsive patients.

Key Points

To compare the blood pressure-lowering effects of isradipine against placebo at the end of a 12-hour dosing interval.
Following a three-week placebo run-in phase, 187 patients who demonstrated prior blood pressure response to isradipine were randomized to double-blind treatment with 2.5 mg isradipine twice daily or placebo for six weeks.
Blood pressure measurements were taken at trough, exactly 12 hours after dose administration.
Diastolic blood pressure normalized (≤90 mm Hg) in 54% (52/96) of patients receiving isradipine compared with 33% (30/87) receiving placebo.
An additional 12% (12/96) of isradipine-treated patients achieved a diastolic blood pressure drop of ≥10 mm Hg without reaching ≤90 mm Hg, versus 6% (5/87) in the placebo group (P = .003).

Study Design

Type

RCT (n=187)

Blinding

Double-blind

Structured PICO

Does isradipine 2.5 mg twice daily improve blood pressure normalization at trough compared to placebo in patients previously responsive to isradipine?

Population

187 patients with high blood pressure who previously responded to isradipine, followed for 6 weeks.

Intervention

Isradipine 2.5 mg twice daily for six weeks

Comparator

Placebo for six weeks

Outcome

Rate of blood pressure normalization (diastolic blood pressure ≤ 90 mm Hg) measured 12 hours after drug administration (trough values)surrogate

Main Result

Absolute Event Rate: 54% vs 33%

p-value: p=.003

Isradipine 2.5 mg twice daily effectively lowers blood pressure and maintains its antihypertensive effect at the end of the dosing interval.

Cite This Study

Veld et al. (1991) conducted an RCT in Hypertension (n=187). Isradipine vs. Placebo was evaluated on Rate of normalization (diastolic blood pressure ≤ 90 mm Hg) (p=.003). Isradipine 2.5 mg twice daily significantly increased the rate of diastolic blood pressure normalization compared to placebo (54% vs 33%; P=.003).

synapsesocial.com/papers/6a95d9530b2d0a0cdf92c7ab https://doi.org/10.1093/ajh/4.2.131s

Topics

Hypertension management

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Isradipine Twice Daily Lowers Blood Pressure Over 24 H

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Topics

Isradipine Twice Daily Lowers Blood Pressure Over 24 H

Discussion

Member takes

Implication

Key Points

Study Design

Structured PICO

Main Result

Cite This Study

Also Consider

Topics

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