| Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. | |
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MedLine Citation:
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PMID: 19683638 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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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:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Lancet Volume: 374 ISSN: 1474-547X ISO Abbreviation: Lancet Publication Date: 2009 Aug |
Date Detail:
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Created Date: 2009-08-17 Completed Date: 2009-08-27 Revised Date: 2010-08-30 |
Medline Journal Info:
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Nlm Unique ID: 2985213R Medline TA: Lancet Country: England |
Other Details:
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Languages: eng Pagination: 525-33 Citation Subset: AIM; IM |
Affiliation:
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Division of Cardiology, Hospital S Maria della Misericordia, Perugia, Italy. verdec@tin.it |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00421863 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Antihypertensive Agents |
| Investigator | |
Investigator/Affiliation:
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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:
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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:
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Lancet. 2009 Sep 12;374(9693):880 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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