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PMID: 16537662 Published · ppublish English Journal Article Multicenter Study Randomized Controlled Trial

Feasibility of treating prehypertension with an angiotensin-receptor blocker.

The New England journal of medicine ·Vol. 354 ·No. 16 ·2006-04-20 ·Pages 1685-97

Julius S, Nesbitt SD, Egan BM, Weber MA, Michelson EL, Kaciroti N, Black HR, Grimm RH, Messerli FH, Oparil S, Schork MA, Trial of Preventing Hypertension TROPHY Study Investigators

Abstract

Prehypertension is considered a precursor of stage 1 hypertension and a predictor of excessive cardiovascular risk. We investigated whether pharmacologic treatment of prehypertension prevents or postpones stage 1 hypertension. Participants with repeated measurements of systolic pressure of 130 to 139 mm Hg and diastolic pressure of 89 mm Hg or lower, or systolic pressure of 139 mm Hg or lower and diastolic pressure of 85 to 89 mm Hg, were randomly assigned to receive two years of candesartan (Atacand, AstraZeneca) or placebo, followed by two years of placebo for all. When a participant reached the study end point of stage 1 hypertension, treatment with antihypertensive agents was initiated. Both the candesartan group and the placebo group were instructed to make changes in lifestyle to reduce blood pressure throughout the trial. A total of 409 participants were randomly assigned to candesartan, and 400 to placebo. Data on 772 participants (391 in the candesartan group and 381 in the placebo group; mean age, 48.5 years; 59.6 percent men) were available for analysis. During the first two years, hypertension developed in 154 participants in the placebo group and 53 of those in the candesartan group (relative risk reduction, 66.3 percent; P<0.001). After four years, hypertension had developed in 240 participants in the placebo group and 208 of those in the candesartan group (relative risk reduction, 15.6 percent; P<0.007). Serious adverse events occurred in 3.5 percent of the participants assigned to candesartan and 5.9 percent of those receiving placebo. Over a period of four years, stage 1 hypertension developed in nearly two thirds of patients with untreated prehypertension (the placebo group). Treatment of prehypertension with candesartan appeared to be well tolerated and reduced the risk of incident hypertension during the study period. Thus, treatment of prehypertension appears to be feasible. (ClinicalTrials.gov number, NCT00227318.).

MeSH Terms
Adult Aged Angiotensin II Type 1 Receptor Blockers/adverse effects,pharmacology,therapeutic use Antihypertensive Agents/adverse effects,pharmacology,therapeutic use Benzimidazoles/adverse effects,pharmacology,therapeutic use Biphenyl Compounds/adverse effects,pharmacology,therapeutic use Blood Pressure/drug effects Double-Blind Method Dyslipidemias/complications,physiopathology Feasibility Studies Female Humans Hypertension/epidemiology,prevention & control Incidence Logistic Models Male Middle Aged Obesity/complications,physiopathology Tetrazoles/adverse effects,pharmacology,therapeutic use
Chemicals
Angiotensin II Type 1 Receptor Blockers Antihypertensive Agents Benzimidazoles Biphenyl Compounds Tetrazoles candesartan cilexetil
Authors & Affiliations
12 authors, click to expand affiliations / ORCID
Julius Stevo
University of Michigan, Department of Internal Medicine, Division of Cardiovascular Medicine, Ann Arbor, MI 48106, USA. sjulius@umich.edu
Nesbitt Shawna D
Egan Brent M
Weber Michael A
Michelson Eric L
Kaciroti Niko
Black Henry R
Grimm Richard H
Messerli Franz H
Oparil Suzanne
Schork M Anthony
Trial of Preventing Hypertension (TROPHY) Study Investigators
Article Info
Journal
The New England journal of medicine
Abbr.
N Engl J Med
ISSN
1533-4406
Published
2006-04-20
Epub
2006-00-14
Pages
1685-97
Language
English
Region
United States
NLM ID
0255562
Subset
IM
Databases
ClinicalTrials.gov
NCT00227318
Corrections
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