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


CONCLUSIONS
Our findings lend support to a lower blood pressure goal than is recommended at present in non-diabetic patients with hypertension.


BACKGROUND
Boehringer-Ingelheim, Sanofi-Aventis, Pfizer.
Verdecchia
Paolo
P
Division of Cardiology, Hospital S Maria della Misericordia, Perugia, Italy. verdec@tin.it
Staessen
Jan A
JA
Angeli
Fabio
F
de Simone
Giovanni
G
Achilli
Augusto
A
Ganau
Antonello
A
Mureddu
Gianfrancesco
G
Pede
Sergio
S
Maggioni
Aldo P
AP
Lucci
Donata
D
Reboldi
Gianpaolo
G
D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D002423:Cause of Death; D004359:Drug Therapy, Combination; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy / Q000517:prevention & control*; D017379:Hypertrophy, Left Ventricular / Q000175:diagnosis / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control; D015994:Incidence; D007558:Italy / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D015995:Prevalence; D016016:Proportional Hazards Models; D040242:Risk Reduction Behavior; D013599:Systole; D016896:Treatment Outcome
D000959:Antihypertensive Agents