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July 1, 2008Journal of Hypertension230 citations

The PHARAO study: prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure – a prospective, randomized, controlled prevention trial of the German Hypertension League

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SLStephan LüdersJSJoachim SchraderJBJürgen Berger

Key Result

Ramipril significantly reduced the progression to manifest hypertension compared to control in patients with high-normal blood pressure (30.7% vs 42.9%; RRR 34.4%, P=0.0001).

Key Points

  • To determine if ramipril can prevent progression to hypertension in patients with high-normal blood pressure.
  • 1008 participants with high-normal blood pressure randomized to ramipril or control group over 3 years
  • Primary endpoint focused on preventing manifest hypertension
  • Secondary endpoints included cardiovascular and cerebrovascular event incidence.
  • 30.7% of the ramipril group and 42.9% of the control group reached the primary endpoint (RR reduction 34.4%, P=0.0001)
  • Ramipril significantly reduced the incidence of manifest hypertension compared to control
  • Cough occurred more frequently in ramipril group (4.8%) than in control (0.4%).

Study Design

Type

RCT (n=1,008)

PICO

P
Population
High-normal blood pressure (n=1,008)
I
Intervention / Comparator
Ramipril vs Control
O
Primary Outcome
Progression to manifest hypertension — RRR 34.4%, p=0.0001

Main Result

Effect estimate: RRR 34.4%

Absolute Event Rate: 30.7% vs 42.9%

p-value: p=0.0001

Abstract

BACKGROUND: The prevention of hypertension with the angiotensin-converting enzyme inhibitor ramipril in patients with high-normal blood pressure study addresses the issue of whether progression to manifest hypertension in patients with high-normal blood pressure can be prevented with treatment. METHODS: A total of 1008 participants with high-normal office blood pressure were randomized to ramipril treatment group (n = 505) and a control group (n = 503). The patients were followed up for 3 years. Primary endpoint was to prevent or delay the progression to manifest hypertension. Secondary endpoints were reduction in the incidence of cerebrovascular and cardiovascular events, as well as the development of hypertension as defined by ambulatory blood pressure monitoring. FINDINGS: One hundred and fifty-five patients (30.7%) in the ramipril group, and 216 (42.9%) in the control group reached the primary endpoint (relative risk reduction 34.4%, P = 0.0001). Ramipril also proved to be more effective in reducing the incidence of manifest office hypertension in patients with baseline ambulatory blood pressure monitoring high-normal blood pressure. The incidence of cerebrovascular and cardiovascular events showed no statistically significant differences between the two groups. Cough was more frequent in the ramipril group (4.8 vs. 0.4%). INTERPRETATION: There is now good clinical evidence that patients with high-normal blood pressure (prehypertension) are more likely to progress to manifest hypertension than patients with optimal or normal blood pressure. Additional ambulatory blood pressure monitoring seems to be essential to achieve correct diagnosis. Treatment of patients with high-normal office blood pressure with the angiotensin-converting enzyme inhibitor was well tolerated, and significantly reduced the risk of progression to manifest hypertension.

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Cite This Study

Lüders et al. (2008) conducted an RCT in High-normal blood pressure (n=1,008). Ramipril vs. Control was evaluated on Progression to manifest hypertension (RRR 34.4%, p=0.0001). Ramipril significantly reduced the progression to manifest hypertension compared to control in patients with high-normal blood pressure (30.7% vs 42.9%; RRR 34.4%, P=0.0001).

synapsesocial.com/papers/6a05120770c113c9996a62b7https://doi.org/10.1097/hjh.0b013e3282ff8864
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