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1. Tight Versus Standard Blood Pressure Control in Patients With Hypertension With and Without Cardiovascular Disease

Author

Reboldi, G, Angeli, F, de Simone, G, Staessen, Ja, Verdecchia, P, Cardio Sis Investigators, Porcellati, C, Fornari, G, 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, Mureddu, Gf, Colivicchi, F, Uguccioni, M, Zanata, G, Martin, G, Mos, L, Martina, S, Dialti, V, Pede, S, Pede, Sa, Ganau, A, 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, A, Achilli, P., Reboldi, G, Angeli, F, DE SIMONE, Giovanni, Staessen, Ja, Verdecchia, P., Galletti, Ferruccio, Epidemiologie, RS: CARIM - R3 - Vascular biology, and Health Services Research

Subjects
Male, systolic blood pressure, Time Factors, Blood Pressure, Disease, law.invention, Electrocardiography, Randomized controlled trial, cardiovascular disease, law, Prospective Studies, Myocardial infarction, Stroke, Incidence, clinical trial, stroke, 3. Good health, Survival Rate, PROGNOSTIC VALUE, left ventricular geometry, myocardial infarction, CARDIO-SIS, Italy, Cardiology, Female, Hypertrophy, Left Ventricular, hypertrophy, medicine.medical_specialty, hypertension, Randomization, LEFT-VENTRICULAR HYPERTROPHY, Internal medicine, Internal Medicine, medicine, Humans, In patient, LVH, Antihypertensive Agents, Aged, randomized controlled trial, left ventricular, prognosis, J-CURVE PHENOMENON, Proportional hazards model, business.industry, Blood Pressure Determination, medicine.disease, RANDOMIZED-TRIAL, Blood pressure, ARTERIAL-HYPERTENSION, business, Follow-Up Studies
Abstract

An excessive blood pressure (BP) reduction might be dangerous in high-risk patients with cardiovascular disease. In the Studio Italiano Sugli Effetti CARDIOvascolari del Controllo della Pressione Arteriosa SIStolica (Cardio-Sis), 1111 nondiabetic patients with systolic BP ≥150 mm Hg were randomly assigned to a systolic BP target P for interaction=0.82). The main secondary end point, a composite of cardiovascular events and all-cause death, occurred less frequently in the tight than in the standard control group both in patients without (1.47 versus 3.68 patient-years; P =0.016) and with (7.87 versus 11.22 patient-years; P =0.049) previous cardiovascular disease. In a multivariable Cox model, allocation to tight BP control reduced the risk of cardiovascular events to a similar extent in patients with or without overt cardiovascular disease at randomization ( P for interaction=0.43). In conclusion, an intensive treatment aimed to lower systolic BP

Published
2014

2. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial

Author

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, and Achilli, P.

Subjects
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
Abstract

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.

Published
2009

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