What question did this study set out to answer?

Assess the efficacy, dose-response, and safety of combining the ACE inhibitor cilazapril with hydrochlorothiazide in patients with mild to moderate hypertension.

November 18, 2008Cardiology

Cilazapril plus Hydrochlorothiazide: Improved Efficacy without Reduced Safety in Mild to Moderate Hypertension

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Why the study?

Does cilazapril plus hydrochlorothiazide combination therapy reduce sitting diastolic blood pressure in patients with mild to moderate hypertension compared to placebo or monotherapy?

Key Points

Assess the efficacy, dose-response, and safety of combining the ACE inhibitor cilazapril with hydrochlorothiazide in patients with mild to moderate hypertension.
Conducted a multicenter, placebo-controlled, double-blind, 4 x 3 factorial randomized trial evaluating 1,162 patients across 12 parallel groups.
Administered oral once-daily treatments for 4 weeks with placebo (n = 97), cilazapril (0.5, 5, or 10 mg; n = 288), hydrochlorothiazide (12.5 or 25 mg; n = 198), or one of six combination regimens (n = 579).
All combination regimens showed statistically significantly greater reductions from baseline in 24-hour postdose sitting diastolic blood pressure compared to placebo and respective monotherapy components (p < 0.01).
The 5 mg cilazapril plus 12.5 mg hydrochlorothiazide combination demonstrated synergistic antihypertensive efficacy and additive blood pressure normalization rates (sitting diastolic blood pressure ≤ 90 mm Hg).
Tolerability profiles for combination regimens were comparable to placebo, with combination therapy reporting lower frequencies of hypokalemia and elevated serum uric acid than hydrochlorothiazide monotherapy.

Structured PICO

Does cilazapril plus hydrochlorothiazide combination therapy reduce sitting diastolic blood pressure in patients with mild to moderate hypertension compared to placebo or monotherapy?

Population

1,162 patients with mild to moderate hypertension

Intervention

Cilazapril (0.5, 5, or 10 mg) plus hydrochlorothiazide (12.5 or 25 mg) combination therapy given orally once daily for 4 weeks

Comparator

Placebo (n=97), cilazapril monotherapy (n=288), or hydrochlorothiazide monotherapy (n=198)

Outcome

Mean decrease from baseline in predose (24 h postdose) sitting diastolic blood pressure (SDBP)surrogate

The combination of cilazapril 5 mg and hydrochlorothiazide 12.5 mg provides synergistic blood pressure reduction with a favorable safety profile compared to monotherapy in mild to moderate hypertension.

Discussion

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Implication

Supports cilazapril-HCTZ combination over monotherapy for BP control in mild-moderate hypertension; extends ACEI-diuretic evidence from this RCT.

Cite This Study

Robert Pordy (2008) studied this question.

synapsesocial.com/papers/6a7c19354e26224dc1ed1fe0 https://doi.org/10.1159/000176704

Topics

Hypertension management

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Implication

Supports cilazapril-HCTZ combination over monotherapy for BP control in mild-moderate hypertension; extends ACEI-diuretic evidence from this RCT.

Cilazapril plus Hydrochlorothiazide: Improved Efficacy without Reduced Safety in Mild to Moderate Hypertension

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Topics

Cilazapril plus Hydrochlorothiazide: Improved Efficacy without Reduced Safety in Mild to Moderate Hypertension

Key Points

Structured PICO

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider