April 1, 2001Journal of Internal MedicineOpen Access

Multiple risk intervention trial in high risk hypertensive men: comparison of ultrasound intima‐media thickness and clinical outcome during 6 years of follow‐up

Q: What is the clinical evidence from this study?

Study design: RCT. Population: High-risk hypertension (n=164). Intervention: Comprehensive risk factor modification programme vs. Usual care. Primary outcome: Total mortality (p=0.028).

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Key result

A comprehensive risk factor modification program reduced total mortality compared to usual care (13% vs 29%, P=0.028) in high-risk hypertensive men over 6 years.

Why the study?

Does a comprehensive risk factor modification programme improve intima-media thickness and clinical outcomes in high-risk hypertensive men?

Population

164 male patients, aged 50-72 years, with treated hypertension and at least one additional risk factor.

Comparison

Comprehensive risk factor modification programme… vs Usual care, with similar antihypertensive…

Design

RCT, 1:1

Follow-up

mean 6.2 years

Authors

SAStefan AgewallPreventive Cardiology BFBjörn FagerbergGeneral / Preventive / Lipids GBG BerglundPreventive Cardiology

Discussion

Member takes

Implication

Supports comprehensive risk factor modification in high-risk hypertensive men; challenges IMT as reliable surrogate for mortality.

Study Design

Type

RCT (n=164)

Randomization

1:1

Structured PICO

Does a comprehensive risk factor modification programme improve intima-media thickness and clinical outcomes in high-risk hypertensive men?

Population

164 high-risk hypertensive men aged 50-72 years with hypercholesterolemia, smoking, or diabetes, followed for a mean of 6.2 years.

Intervention

Comprehensive risk factor modification programme including education, diet recommendations, weight loss, smoking cessation, glucose monitoring, and lipid-lowering drugs if goals not met, with follow-up every 6 months.

Comparator

Usual care (advice to quit smoking and lower fat/glucose consumption), with similar antihypertensive treatment.

Outcome

Intima-media thickness (IMT) of the common carotid artery as measured by ultrasound, and cardiovascular events during follow-up.surrogate

Main Result

Absolute Event Rate: 13% vs 29%

p-value: p=0.028

A comprehensive risk factor intervention program significantly reduced total mortality in high-risk hypertensive men, while demonstrating that surrogate endpoints like IMT can be misleading in long-term studies due to survival bias.

Limitations

Missing data in patients where a large increase in IMT would have been observed, had they been re-examined (survival bias).
Missing data in patients with positive plaque status who died, leading to survival bias for the surrogate endpoint

Cite This Study

Agewall et al. (2001) conducted an RCT in High-risk hypertension (n=164). Comprehensive risk factor modification programme vs. Usual care was evaluated on Total mortality (p=0.028). A comprehensive risk factor modification program reduced total mortality compared to usual care (13% vs 29%, P=0.028) in high-risk hypertensive men over 6 years.

synapsesocial.com/papers/6a93da5e55081e739f43d6ff https://doi.org/10.1046/j.1365-2796.2001.00818.x

Topics

Hypertension management

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Multiple risk intervention trial in high risk hypertensive men: comparison of ultrasound intima‐media thickness and clinical outcome during 6 years of follow‐up

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Topics

Multiple risk intervention trial in high risk hypertensive men: comparison of ultrasound intima‐media thickness and clinical outcome during 6 years of follow‐up

Discussion

Member takes

Implication

Study Design

Structured PICO

Main Result

Limitations

Cite This Study

Also Consider

Topics

Also Consider