Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial
| Autor: | Verdecchia, P, Staessen, Ja, Angeli, F, de Simone, G, Achilli, A, Ganau, A, Mureddu, G, Pede, S, Maggioni, Ap, Lucci, D, Reboldi, G, Porcellati, C, Fornari, G, Ceseri, M, Lorimer, A, Repaci, S, Castellani, C, Mazzotta, G, Berioli, S, Jaspers, C, Cucchiara, G, Panzano, C, Sclavo, Mg, Scherillo, M, Raucci, D, Faggiano, P, Porcu, M, Pistis, L, Vancheri, F, Curcio, M, Ieva, M, Muscella, A, Guerrieri, M, Dembech, C, Gulizia, Mm, Francese, Gm, Perticone, F, Iemma, G, Zanolini, G, Pierdomenico, Sd, Mezzetti, A, Benemio, G, Gattobigio, R, Sacchi, N, Cocchieri, M, Prosciutti, L, Garognoli, O, Pirelli, S, Emanuelli, C, Galeazzi, G, Abrignani, Mg, Lombardo, R, Braschi, Gb, Leoncini, G, Igidbashian, D, Marini, R, Mandorla, S, Buccolieri, M, Picchi, L, Casolo, G, Pardini, M, Galletti, F, Barbato, A, Cavallini, C, Borgioni, C, Sardone, Mg, Cipollini, F, Seghieri, G, Arcangeli, E, Boddi, W, Palermo, C, Lembo, G, Malatino, L, Leonardis, D, Gentile, C, Boccanelli, A, Colivicchi, F, Uguccioni, M, Zanata, G, Martin, G, Mos, L, Martina, S, Dialti, V, Pede, Sa, Farina, G, Tripodi, E, Miserrafiti, B, Stornello, M, Valvo, Ev, Proietti, G, Bernardinangeli, M, Poddighe, G, Marras, Ma, Biscottini, B, Panciarola, R, Veglio, Franco, Mulatero, Paolo, Caserta, Ma, Chiatto, M, Cioffi, G, Bonazza, G, Achilli, P. |
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| Jazyk: | angličtina |
| Rok vydání: | 2009 |
| Předmět: |
Male
systolic blood pressure Hemodynamics Kaplan-Meier Estimate 030204 cardiovascular system & hematology Left ventricular hypertrophy ipertensione trial clinico ipertrofia cardiaca law.invention Electrocardiography 0302 clinical medicine Randomized controlled trial law Cause of Death Prevalence Clinical endpoint Medicine 030212 general & internal medicine Incidence General Medicine Aged Antihypertensive Agents Cardiovascular Diseases Drug Therapy Hypertension Treatment Outcome Left Ventricular Hypertrophy Randomised Controlled Trial 3. Good health Italy anti-hypertensive therapy Cardiology Drug Therapy Combination Female Hypertrophy Left Ventricular medicine.medical_specialty Systole Prehypertension 03 medical and health sciences Internal medicine Diabetes mellitus Humans blood pressure control systoli hypertension Proportional Hazards Models Intention-to-treat analysis business.industry medicine.disease Surgery Logistic Models Blood pressure Linear Models business Risk Reduction Behavior Follow-Up Studies |
| ISSN: | 0042-1863 |
| Popis: | 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.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.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], p0.0001; 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.Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension.Boehringer-Ingelheim, Sanofi-Aventis, Pfizer. |
| Databáze: | OpenAIRE |
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