SILVHIA 2001.
Methods | Allocation: randomized Blindness: double‐blinded Duration: 48 weeks Funding: Karolinska Institutet, Stockholm, Sweden, the Swedish Heart‐Lung Foundation,Stiftelsen Serafimerlasarettet, Stockholm, Sweden, Bristol‐Myers Squibb Pharmaceutical Research Institute, Princeton, NJ, USA, and Sanofi‐Synthelabo, Paris, France |
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Participants | Diagnosis: Mild‐to‐moderate hypertension and left ventricular hypertrophy N = 101 Age: Irbesartan group 54 ± 8 years; Atenolol group 54 ± 10 years Sex: 32% women; 68% men History: Mild‐to‐moderate hypertension and LV hypertrophy Inclusion criteria: Women with mild‐to‐moderate hypertension and LV hypertrophy. All antihypertensive agents were withdrawn appropriately before the start of a 4‐ to 6‐week single‐blind placebo lead‐in period. At the end of the placebo period, participants were determined eligible for the double‐blind part of the study if the mean of 3 seated diastolic blood pressures (SeDBP) taken 1 min apart was 90 ‐ 115 mmHg on 2 consecutive visits, with values differing no more than 8 mmHg Exclusion criteria: If patients had an LV ejection fraction < 45%, any significant concomitant diseases, or were taking any other medications that might interfere with the efficacy assessments or that would present safety hazards |
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Interventions | RAS inhibitor: Irbesartan; beta‐blocker: atenolol Irbesartan 150 mg/d Atenolol 50 mg/d If SeDBP was > 90 mmHg after 6 weeks,irbesartan 300 mg/d or atenolol 100 mg/d If SeDBP remained > 90 mmHg at week 12, open‐label hydrochlorothiazide (HCTZ) 12.5 mg/d (titrated to 25 mg if necessary) At week 24, open‐label felodipine 5 ‐ 10 mg/d if required At the end of the study, 40% of participants in the irbesartan group and 49% in the atenolol group remained on the monotherapy. |
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Outcomes | 1. Blood pressure: At all clinic visits, trough (24 ± 3 h after the last dose) SeSBP and SeDBP were measured using a mercury sphygmomanometer. After resting for at least 10 mins in the seated position, blood pressure was determined as the average of 3 replicate measurements taken 1 min apart 2. Heart rate: Heart rate was then recorded in the seated position 3. Total peripheral resistance: Mean arterial pressure was calculated as SeDBP + (SeSBP ‐ SeDBP)/3. Total peripheral was calculated by dividing mean arterial pressure by cardiac output (i.e. stroke volume 3 heart rate), and expressed as peripheral resistance units (PRU) 4. Echocardiography (LVMI, left ventricular mass index; IVS, intraventricular septum; PWT, posterior wall thickness; LVEDD, left ventricular end‐diastolic diameter; RWT, relative wall thickness; EF, ejection fraction.): Echocardiography was performed with the woman in the left semilateral position. The ultrasound devices used were the Acuson 128 X P/10 (Mountain View, California, USA), Vingmed CFM 750 (Vingmed Sound,Horten, Norway) and HP SONOS 2500 (Andover,Massachusetts, USA). Measurements were performed on 3 ‐ 5 consecutive beats, from which the mean values were calculated. Basic measurements of LV dimensions in diastole (LVEDD) and systole (LVESD), and intra‐ventricular septum (IVS) thickness and posterior wall thickness in diastole (PWT) were made by M‐mode technique The ejection fraction was measured according to the recommendations of the American Society of Echocardiography |
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Notes | New for 2018 update | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation was not described |
Allocation concealment (selection bias) | Unclear risk | Method of concealment was not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of blinding was not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data were unlikely to have an impact on the results of the trial |
Selective reporting (reporting bias) | Low risk | All of the study's prespecified outcomes that are of interest in the review have been reported in the prespecified way |
Other bias | High risk | Number of participants reported in different outcomes are not consistent |