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1. 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

2. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population

Author

VERDECCHIA P, CARDIO SIS STUDY G. R. O. U. P., Staessen, Ja, Achilli, A, DE SIMONE, G, Ganau, A, Mureddu, G, Pede, S, Porcellati, C, Fornari, G, Repaci, S, Castellani, C, Achilli, P, Jaspers, C, Cucchiara, G, Panzano, C, Angeli, F, Aillon, C, Sclavo, Mg, Scherillo, M, Raucci, D, DI DONATO, M, Cas, Ld, Faggiano, P, Porcu, M, Calamida, R, Pistia, L, Vancheri, F, Alletto, M, Curcio, M, Pettinati, G, Ieva, M, Muscella, A, Guerrieri, M, Denbek, C, Gulizia, M, Francese, Gm, Perticone, F, Iemma, G, Fariello, R, Sala, N, Mezzetti, A, Pierdomenico, Sd, Bucci, M, Benemio, G, Gattobigio, R, Sacchi, N, Cocchieri, M, Prosciutti, L, Battocchi, P, Garognoli, O, Arcelli, G, Pirelli, S, Emanuelli, C, Braschi, Gb, Abrignani, M, DE FERRARI, G, Ponremoli, R, Igidbashian, D, Marini, R, Scarpino, L, Mandorla, S, Buccolieri, M, Picchi, L, Casolo, G, Pardini, M, Marracci, G, Strazzullo, P, Galletti, F, Barbato, A, Cavallini, C, Borgioni, C, Seghieri, G, Cipollini, F, Arcangeli, E, Boddi, W, Palermo, C, Savelli, F, Lembo, G, Vecchione, C, Malatino, Lorenzo, Belluardo, P, Zoccali, C, Leonerdis, D, Mallamaci, F, Lacchè, A, Gentile, C, Boccanelli, A, Mureddu, Gf, Santini, M, Colivicchi, F, Ficili, S, Uguccioni, M, Nardozi, C, Tedeschi, A, Martin, G, Zanata, G, Mos, L, Dialti, V, Martina, S, Renna, A, Farina, G, Tripodi, E, Miserrafiti, B, Scali, R, Stornello, M, Valvo, E, Bernardinangeli, M, Proietti, G, Poddighe, G, Biscottini, B, Panciarola, R, Boccali, A, Veglio, F, Rabbia, F, Caserta, M, Chiatto, M, Stefenelli, C, Cioffi, G, Bonazza, G, Scabbia, Ev, and Bottoni, D.

Published
2008

4. Randomized study of traditional versus aggressive systolic blood pressure control (Cardio-Sis): rationale, design and characteristics of the study population

Author

Ceseri, M., Angeli, F., Achilli, A., Achilli, P., Panzano, C., Lucci, D., Porcellati, C., Lorimer, A., Maggioni, Ap, Castellani, C., Cucchiari, G., Staessen, Jan A., Mureddu, G., Repaci, S., Jaspers, C., Fornari, G., Simone, G., Pede, S., the Cardio-Sis Study Group, Verdecchia, P., Ganau, A., Cardio Sis Study, Group, and Strazzullo, Pasquale

Subjects
Male, medicine.medical_specialty, hypertension, electrocardiography, ipertrofia cardiaca, left ventricular hypertrophy, pressione arteriosa, prognosi, prognosis, systolic blood pressure, Systole, population, Blood Pressure, 030204 cardiovascular system & hematology, Severity of Illness Index, Prehypertension, law.invention, Electrocardiography, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Internal Medicine, medicine, Humans, Prospective Studies, 030212 general & internal medicine, cardiovascular diseases, Antihypertensive Agents, Aged, business.industry, Blood Pressure Determination, Prognosis, 3. Good health, Pulse pressure, Blood pressure, Aortic pressure, Cardiology, Population study, Female, Hypertrophy, Left Ventricular, business, Follow-Up Studies
Abstract

The hypothesis that a therapeutic strategy aimed at lowering systolic blood pressure (SBP) below 130 mm Hg is superior to a conventional strategy targeted at below 140 mm Hg in hypertensive subjects has never been tested in randomized intervention studies. The Studio Italiano Sugli Effetti Cardiovascolari del Controllo della Pressione Arteriosa Sistolica (Cardio-Sis) is a multi-centre study in non-diabetic, treated hypertensive subjects aged >55 years with uncontrolled SBP (>or=150 mm Hg) and at least one additional cardiovascular risk factor (ClinicalTrials.gov identifier: NCT00421863). Subjects are randomized to an SBP goal

5. Effects of barnidipine on blood pressure and left ventricular diastolic function in patients with hypertension and metabolic syndrome: A 12-week, open-label noncomparison study.

Author

Angeli F, Repaci S, Borgioni C, Sardone M, Scotti A, and Verdecchia P

Abstract

Background: Barnidipine is one of a new generation of dihydropyridine calcium-channel blockers. Despite evidence of favorable effects on blood pressure (BP) and insulin sensitivity, this drug has rarely been tested in hypertensive patients with metabolic syndrome (MS)., Objective: The aim of this study was to evaluate the effects of barnidipine on BP and left ventricular (LV) diastolic function in patients with hypertension and MS., Methods: Consecutive subjects aged 18 to 75 years with systolic BP (SBP) of 140 to 179 mm Hg and/or diastolic BP (DBP) of 90 to 109 mm Hg and MS (based on Adult Treatment Panel III criteria) were assessed for inclusion in the study. Lifestyle changes according to current guidelines were recommended and barnidipine monotherapy 10 mg daily was initiated. All patients entered a 2-week run-in period. After a 6-week treatment period, the daily dosage was doubled for the remainder of the study in patients whose BP remained uncontrolled (≥140/≥90 mm Hg). We assessed the glycolipidic profile and LV structure and function using standard Doppler and tissue Doppler imaging (TDI) echocardiography before and after 12 weeks of treatment. Ambulatory BP records and electrocardiographic and echocardiographic tracings were coded and shipped to a central laboratory for blinded analysis. Possible adverse events (AEs) were recorded at predetermined intervals throughout the follow-up period and at unplanned intervals whenever an AE became known to the investigators., Results: Thirty-four consecutive patients were assessed for inclusion. Thirty consecutive patients (20 men, 10 women; mean {SD| age, 55.9 {10.3| years; 5 current smokers) were included in the study. At study entry, mean office SBP was 146 mm Hg, DBP was 87 mm Hg, and heart rate was 72 beats/min. At the study end, mean office SBP/DBP was <140/90 mm Hg in 20 patients (66.7%). From baseline to study end, 24-hour ambulatory BP decreased significantly by 12 and 8 mm Hg for SBP and DBP, respectively (both, P = 0.001). The smoothness index was 0.92 for SBP and 0.82 for DBP. Fasting plasma glucose concentration decreased significantly from 110 to 104 mg/dL (P = 0.001). Total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol concentrations did not change significantly. From baseline to study end, there were no significant changes in LV structure or systolic function (LV mass, 50.7 vs 50.6 g/ht(2.7); LV diastolic/systolic diameters, 47.50/29.80 vs 48.40/30.76 mm; wall motion score index, 1.0 vs 1.0; ejection fraction, 61% vs 60%), while the peak E/A velocity ratio on TDI increased from 1.078 to 1.245 (P = 0.009). No AEs (including AEs reflected by chemistry values) either unrelated or related to treatment were noted during the 12-week duration of the study., Conclusions: In these hypertensive patients with MS, a 12-week treatment period with barnidipine in addition to lifestyle modifications was associated with significant reductions in 24-hour BP and BP variability, reduction in plasma glucose concentration, and improvement in LV diastolic relaxation. No significant changes in lipid concentrations, LV structure, or systolic function were found.

Published
2008
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