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January 1, 1997American Journal of HypertensionOpen Access

Use of the Factorial Design and Quadratic Response Surface Models to Evaluate the Fosinopril and Hydrochlorothiazide Combination Therapy in Hypertension

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Why the study?

Does fosinopril and hydrochlorothiazide combination therapy reduce blood pressure in patients with mild to moderate hypertension?

Population

550 patients with mild to moderate hypertension

Comparison

Fosinopril and hydrochlorothiazide combination… vs Placebo, fosinopril monotherapy, or…

Design

RCT, modified 4 x 4 factorial randomized, double-blind

Follow-up

8 weeks

Authors

JPJames L. PoolAnglia Ruskin University

Discussion

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Implication

Supports fosinopril-HCTZ combinations for greater DBP reduction; confirms additive effects via quadratic modeling in mild-moderate hypertension.

Key Points

  • To evaluate the antihypertensive efficacy and dose-response interactions of fosinopril combined with hydrochlorothiazide in patients with mild to moderate hypertension using quadratic response surface models.
  • Conducted a modified 4 x 4 factorial, randomized, double-blind, placebo-controlled, parallel-group trial in 550 patients with mild to moderate hypertension across 17 different doses of fosinopril and hydrochlorothiazide.
  • Fitted 8-week seated systolic and diastolic blood pressure response data to quadratic response surface models using polynomial functions to model actual and interpolated dose effects.
  • Fosinopril and hydrochlorothiazide alone and in combination demonstrated dose-related, additive reductions in seated systolic and diastolic blood pressure.
  • Combination therapy of 10 mg fosinopril plus 12.5 mg hydrochlorothiazide reduced adjusted mean seated diastolic blood pressure by 6.3 mm Hg, while 20 mg fosinopril plus 12.5 mg hydrochlorothiazide lowered it by 9.1 mm Hg.

Structured PICO

Does fosinopril and hydrochlorothiazide combination therapy reduce blood pressure in patients with mild to moderate hypertension?

P
Population
550 patients with mild to moderate hypertension
I
Intervention
Fosinopril and hydrochlorothiazide combination therapy (17 different doses)
C
Comparator
Placebo, fosinopril monotherapy, or hydrochlorothiazide monotherapy
O
Outcome
Seated systolic (SeSBP) and diastolic blood pressure (SeDBP) responses at 8 weekssurrogate

The combination of fosinopril and hydrochlorothiazide produces an additive blood pressure-lowering effect in patients with mild to moderate hypertension, which can be accurately modeled using quadratic response surface models.

Cite This Study

James L. Pool (1997) studied this question.

synapsesocial.com/papers/6a70e40226770c2b8de0d02ahttps://doi.org/10.1016/s0895-7061(96)00323-8

Topics

Hypertension management
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Short report: Ramipril and hydrochlorothiazide combination therapy in hypertension: a clinical trial of factorial design1993 · 41 citations
  2. 2An assessment of diltiazem and hydrochlorothiazide in hypertension. Application of factorial trial design to a multicenter clinical trial of combination therapy1990 · 58 citations
  3. 3Cross-Over Factorial Studies with Antihypertensive Drugs2008 · 5 citations
  4. 4Controlled Multicenter Study of the Antihypertensive Effects of Lisinopril, Hydrochlorothiazide, and Lisinopril plus Hydrochlorothiazide in the Treatment of 394 Patients with Mild to Moderate Essential Hypertension1987 · 76 citations
  5. 5Hypertension: Steps Forward and Steps Backward1993 · 53 citations