Document Detail


Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial.
MedLine Citation:
PMID:  19683638     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The level to which systolic blood pressure should be controlled in hypertensive patients without diabetes remains unknown. We tested the hypothesis that tight control compared with usual control of systolic blood pressure would be beneficial in such patients. METHODS: In this randomised open-label trial undertaken in 44 centres in Italy, 1111 non-diabetic patients with systolic blood pressure 150 mm Hg or greater were randomly assigned to a target systolic blood pressure of less than 140 mm Hg (usual control; n=553) or less than 130 mm Hg (tight control; n=558). After stratification by centre, we used a computerised random function to allocate patients to either group. Observers who were unaware of randomisation read electrocardiograms and adjudicated events. Open-label agents were used to reach the randomised targets. The primary endpoint was the rate of electrocardiographic left ventricular hypertrophy 2 years after randomisation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00421863. RESULTS: Over a median follow-up of 2.0 years (IQR 1.93-2.03), systolic and diastolic blood pressure were reduced by a mean of 23.5/8.9 mm Hg (SD 10.6/7.0) in the usual-control group and by 27.3/10.4 mm Hg (11.0/7.5) in the tight-control group (between-group difference 3.8 mm Hg systolic [95% CI 2.4-5.2], p<0.0001; and 1.5 mm Hg diastolic [0.6-2.4]; p=0.041). The primary endpoint occurred in 82 of 483 patients (17.0%) in the usual-control group and in 55 of 484 patients (11.4%) of the tight-control group (odds ratio 0.63; 95% CI 0.43-0.91; p=0.013). A composite cardiovascular endpoint occurred in 52 (9.4%) patients in the usual-control group and in 27 (4.8%) in the tight-control group (hazard ratio 0.50, 95% CI 0.31-0.79; p=0.003). Side-effects were rare and did not differ significantly between the two groups. INTERPRETATION: Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension. FUNDING: Boehringer-Ingelheim, Sanofi-Aventis, Pfizer.
Authors:
Paolo Verdecchia; Jan A Staessen; Fabio Angeli; Giovanni de Simone; Augusto Achilli; Antonello Ganau; Gianfrancesco Mureddu; Sergio Pede; Aldo P Maggioni; Donata Lucci; Gianpaolo Reboldi;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  374     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-17     Completed Date:  2009-08-27     Revised Date:  2010-08-30    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  525-33     Citation Subset:  AIM; IM    
Affiliation:
Division of Cardiology, Hospital S Maria della Misericordia, Perugia, Italy. verdec@tin.it
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00421863
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MeSH Terms
Descriptor/Qualifier:
Aged
Antihypertensive Agents / therapeutic use
Cardiovascular Diseases / diagnosis,  epidemiology,  etiology,  prevention & control
Cause of Death
Drug Therapy, Combination
Electrocardiography
Female
Follow-Up Studies
Humans
Hypertension / complications,  drug therapy,  prevention & control*
Hypertrophy, Left Ventricular / diagnosis,  epidemiology,  etiology*,  prevention & control
Incidence
Italy / epidemiology
Kaplan-Meiers Estimate
Linear Models
Logistic Models
Male
Prevalence
Proportional Hazards Models
Risk Reduction Behavior
Systole
Treatment Outcome
Chemical
Reg. No./Substance:
0/Antihypertensive Agents
Investigator
Investigator/Affiliation:
Paolo Verdecchia / ; Jan A Staessen / ; Augusto Achilli / ; Giovanni de Simone / ; Antonello Ganau / ; Gianfrancesco Mureddu / ; Sergio Pede / ; Fabio Angeli / ; Aldo P Maggioni / ; Gianpaolo Reboldi / ; Carlo Porcellati / ; Giovanni Fornari / ; Martina Ceseri / ; Donata Lucci / ; Andrea Lorimer / ; Salvatore Repaci / ; Claudia Castellani / ; Giovanni Mazzotta / ; Silvano Berioli / ; Carla Jaspers / ; Giovanni Cucchiara / ; Carlo Panzano / ; M G Sclavo / ; M Scherillo / ; D Raucci / ; P Faggiano / ; M Porcu / ; L Pistis / ; F Vancheri / ; M Curcio / ; M Ieva / ; A Muscella / ; M Guerrieri / ; C Dembech / ; M M Gulizia / ; G M Francese / ; F Perticone / ; G Iemma / ; G Zanolini / ; S D Pierdomenico / ; A Mezzetti / ; G Benemio / ; R Gattobigio / ; N Sacchi / ; M Cocchieri / ; L Prosciutti / ; O Garognoli / ; S Pirelli / ; C Emanuelli / ; G Galeazzi / ; M G Abrignani / ; R Lombardo / ; G B Braschi / ; G Leoncini / ; D Igidbashian / ; R Marini / ; S Mandorla / ; M Buccolieri / ; L Picchi / ; G Casolo / ; M Pardini / ; F Galletti / ; A Barbato / ; C Cavallini / ; C Borgioni / ; M G Sardone / ; F Cipollini / ; G Seghieri / ; E Arcangeli / ; W Boddi / ; C Palermo / ; G Lembo / ; L Malatino / ; D Leonardis / ; C Gentile / ; A Boccanelli / ; F Colivicchi / ; M Uguccioni / ; G Zanata / ; G Martin / ; L Mos / ; S Martina / ; V Dialti / ; S A Pede / ; G Farina / ; E Tripodi / ; B Miserrafiti / ; M Stornello / ; E V Valvo / ; G Proietti / ; M Bernardinangeli / ; G Poddighe / ; M A Marras / ; B Biscottini / ; R Panciarola / ; F Veglio / ; P Mulatero / ; M A Caserta / ; M Chiatto / ; G Cioffi / ; G Bonazza / ; P Achilli /
Comments/Corrections
Comment In:
Am J Kidney Dis. 2010 Sep;56(3):434-8   [PMID:  20570424 ]
J Clin Hypertens (Greenwich). 2010 Feb 1;12(2):109-11   [PMID:  20167035 ]
Lancet. 2009 Nov 21;374(9703):1741; author reply 1742   [PMID:  19932349 ]
Ann Intern Med. 2009 Nov 17;151(10):JC5-7   [PMID:  19920265 ]
Lancet. 2009 Nov 21;374(9703):1741-2; author reply 1742   [PMID:  19932348 ]
Lancet. 2009 Aug 15;374(9689):503-4   [PMID:  19683626 ]
Erratum In:
Lancet. 2009 Sep 12;374(9693):880

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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