Shanghai Trial Of Nifedipine in the Elderly - STONE

May 15, 2002
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Date Presented:
01/01/1996
Date Published:
01/01/1996
Date Updated:
05/15/2002
Original Posted Date:
05/15/2002
References

Description:

Long-acting nifedipine vs placebo in hypertension.

Hypothesis:

To determine if there is a difference between nifedipine and placebo in the incidence of cardiovascular events in elderly hypertensive patients

Study Design

Study Design:

Patients Screened: Not reported
Patients Enrolled: 1632
NYHA Class: Not reported
Mean Follow Up: mean 30 months
Mean Patient Age: 60-79 (mean 66.4)
Female: 53%
Mean Ejection Fraction: Not evaluated

Patient Populations:

60–79 years of age with blood pressure ≥160/90 mm Hg.

Exclusions:

SBP 220 mmHg or greater, DBP 125 mmHg or greater, secondary hypertension, severe arrhythmia (including >10 VPCs/minute), atrial fibrillation, second-degree AV block, history of stroke, CHF, angina, MI, or other serious diseases

Primary Endpoints:

Stroke, CHF, MI, severe arrhythmia, sudden death.

Drug/Procedures Used:

There was a 4-week placebo run-in phase then randomization occurred to slow-release nifedipine (10–60 mg twice daily) or placebo. Captopril or dihydrochlorothiazide was added if blood pressure remained elevated (>159/90 mmHg).

Principal Findings:

Overall, 65% of subjects in active treatment group attained the blood pressure goal ((SBp <160 mmHg, DBP <90 mmHg). The SBP decline was 21.7 mmHg in the nifedipine group versus 12.3 in placebo group(p<0.0001). At a mean follow-up of 30 months, the nifedipine group had experienced significantly fewer clinical end points, including MI, sudden death, congestive heart failure, and stroke (3.9% vs. 7.4%). Specifically, there were >50% fewer strokes in nifedipine group compared to the placebo group (p=0.003). A Cox proportional hazrds model revealed that age, smoking, and DBP were significant predictors of clinical events in the placebo group.

Interpretation:

Long-acting nifedipine was associated with a reduction in the incidence of major clinical events in elderly hypertensive patients. In particular, this study demonstrates that aggressive blood control significantly reduces the incidence of stroke.

References:

J Hypertens 1996;14:1237–1245.

Keywords: Stroke, Follow-Up Studies, Heart Failure, Hydrochlorothiazide, Nifedipine, Captopril, Hypertension, Death, Sudden, Cardiac, Calcium Channel Blockers, Smoking


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