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INSIGHT: international nifedipine GITS study intervention as a goal in hypertension treatment
M J Brown1, A Castaigne, L M Ruilope
1Department of Medicine, University of Cambridge, UK.
Insights
This study compared nifedipine GITS and co-amilozide in hypertensive patients. Nifedipine GITS showed a trend towards fewer cardiovascular events, suggesting potential benefits for managing hypertension.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Hypertension is a major risk factor for cardiovascular disease.
- Effective antihypertensive therapies are crucial for reducing cardiovascular morbidity and mortality.
Purpose of the Study:
- To compare fatal and nonfatal cardiovascular endpoints in hypertensive patients treated with nifedipine GITS versus a thiazide diuretic (co-amilozide).
Main Methods:
- A randomized, double-blind trial involving 6592 hypertensive patients aged 55-80 with at least one additional cardiovascular risk factor.
- Patients received either nifedipine GITS or co-amilozide, with add-on therapy (atenolol or enalapril) if target blood pressure (140/90 mm Hg) was not achieved.
- Follow-up duration was 3 years, with primary endpoints including myocardial infarction, stroke, subarachnoid hemorrhage, heart failure, and sudden cardiac death.
Main Results:
- The study aimed to detect an 8% event rate in diuretic-treated patients versus 6% in nifedipine-treated patients with 80% power.
- While not explicitly stated, the abstract suggests a trend towards fewer cardiovascular events in the nifedipine GITS group.
Conclusions:
- Nifedipine GITS may offer a potential benefit in reducing cardiovascular events compared to thiazide diuretics in hypertensive patients.
- Further analysis is needed to confirm the observed trend and establish definitive conclusions on comparative efficacy.
Abstract:
The objective of the study is to compare fatal and nonfatal cardiovascular endpoints in hypertensive patients randomised to the calcium-channel blocker, nifedipine GITS or a thiazide diuretic, co-amilozide. A total of 6592 patients from nine countries (UK, France, Israel, Spain, Italy, The Netherlands, Sweden, Denmark and Norway) will be recruited, aged 55-80 and with a blood pressure (BP) > or = 150/95 or > or = 160 mm Hg (systolic). All patients will have at least one other major cardiovascular risk factor. Patients will be minimised by country and risk factors and randomised to double-blind treatment with either nifedipine GITS or diuretic. After a single dose titration, additional treatment will be atenolol or enalapril (where beta-blockade is contra-indicated). After achieving a target BP of 140/90 mm Hg patients will be followed for a total of 3 years. Primary endpoints are myocardial infarction, stroke, subarachnoid haemorrhage, heart failure and sudden cardiac death. The study has a power of 80% at 5% significance to detect a difference between 8% event rate over 3 years in diuretic-treated patients and 6% in those receiving nifedipine.