Principal results from the International Nifedipine GITS Study: Intervention as a Goal in Hypertension Treatment (INSIGHT)

M. J. Brown, C. R. Palmer, A. Castaigne, P. W. De Leeuw, G. Mancia, T. Rosenthal, L. M. Ruilope

Research output: Contribution to journalArticlepeer-review

Abstract

Background: We compared the effects of a long-acting calcium-channel blocker with a thiazide-amiloride combination on cardiovascular mortality and morbidity in patients with additional cardiovascular risk factors. The primary objective was to demonstrate 25% superiority of nifedipine GITS. A secondary objective was to establish non-inferiority compared with co-amilozide. Methods: A prospective, randomized, double-masked trial was carried out in Europe and Israel, involving 6321 patients of 55-80 years of age with hypertension (blood pressure ≥ 150/95 mmHg or systolic ≥ 160 mmHg). Patients were also required to have at least one out of ten additional cardiovascular risk factors, such as diabetes or hypercholesterolaemia. Patients were assigned randomly to initial treatment with either nifedipine GITS (N), 30 mg, or co-amilozide (C) (hydrochlorothiazide, 25 mg, and amiloride, 2.5 mg), so that similar numbers of patients with each risk factor could be compared between the two drugs. Dose titration was principally by dose doubling, and addition of atenolol, 25-50 mg, or enalapril, 5-10 mg. Patients were followed for a mean period of 3 years. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, heart failure or stroke. Secondary outcome variables included death from any cause. Superiority analysis was of time to first event, by intention-to-treat. Non-inferiority analysis required the difference (Δ) in event-rate, and the 95% CI around Δ, to be

Original languageEnglish
JournalEuropean Heart Journal, Supplement
Volume3
Issue numberB
DOIs
Publication statusPublished - 2001

Keywords

  • Hypertension
  • INSIGHT
  • Nifedipine GITS
  • Thiazide-amilozide

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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