ELSA 2002.
| Methods | Multicentre study Randomisation: computer‐generated, using separate lists for each centre with a block size of 4. Participants and study personnel, excluding the Safety Committee, were blinded to treatment assignment for study duration Loss to follow‐up: 3.9% Mean duration of follow‐up: 3.75 years Analyses: by intention‐to‐treat |
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| Participants | Geographic location: France, Germany, Greece, Italy, Spain, Sweden, UK Study setting: 410 clinical units Number of participants: 2334 (54.8% men) Age range: 45 to 75 years (mean: 56 years) Entry criteria: sitting SBP 150 mmHg to 210 mmHg and DBP 95 mmHg to 115 mmHg, fasting serum total cholesterol concentration ≤ 320 mg/dL, fasting serum triglyceride concentration ≤ 300 mg/dL, and serum creatinine concentration ≤ 1.7 mg/dL Race: 98.2% white Main exclusion criteria: recent MI or stroke and insulin‐dependent diabetes mellitus Mean BP at entry: 163.5/101.3 mmHg Comorbid conditions: current smoking (20.5%), ≥ 1 plaque (64%), previous antihypertensive therapy (63%), diabetes, hyperlipidaemia |
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| Interventions |
Beta‐blocker group: Atenolol 50 mg once daily Calcium‐channel blocker group: Lacidipine 4 mg once daily If satisfactory BP control was not achieved, lacidipine could be increased to 6 mg and atenolol to 100 mg (month 1), with open‐label hydrochlorothiazide added (12.5 mg/day (month 3) and 25 mg/day (month 6)) |
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| Outcomes | Change in mean maximum intima‐media thickness Plaque number Fatal and non‐fatal cardiovascular events Total mortality |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation sequence computer‐generated |
| Allocation concealment (selection bias) | Unclear risk | Not adequately described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and personnel blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blind outcome assessment |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Loss to follow‐up: 3.9%. Not indicated whether reasons for missing outcome data were similar across treatment groups |
| Selective reporting (reporting bias) | Low risk | All outcomes reported as stated in protocol. |
| Other bias | Unclear risk | Other antihypertensive drugs added to randomly allocated treatment to control BP. The observed effects may equally have resulted from the different additional drugs. |