INSIGHT 2000.
Methods | Multicentre, randomised, double‐blind, clinical trial Mean follow‐up: 3.5 years |
Participants | Inclusion criteria: aged 55 to 80 years with hypertension (blood pressure ≥ 150/95 mmHg or ≥ 160 mmHg systolic) and at least 1 additional cardiovascular risk factor: hypercholesterolaemia; smoker (10 cigarettes per day currently or up to 1 year before entry); family history of myocardial infarction in parent or sibling before age 50 years; current left‐ventricular hypertrophy, coronary heart disease; left‐ventricular strain; peripheral vascular disease Countries: Denmark, France, Israel, Italy, the Netherlands, Norway, Spain, Sweden, the UK |
Interventions | Monotherapy: initially nifedipine 30 mg daily Combination therapy: hydrochlorothiazide 25 mg + amiloride 2.5 mg daily Dose titration was by dose doubling, and addition of atenolol 25 to 50 mg or enalapril 5 to 10 mg in people whose blood pressure fell by < 20/10 mmHg or was > 140/90 mmHg |
Outcomes | Primary: cardiovascular death, myocardial infarction, heart failure or stroke Secondary: total mortality; death from a vascular cause; and non‐fatal vascular events including transient ischaemic attacks, angina (new or worsening), and renal failure; serious adverse events |
Notes | We requested data for outcomes of interest in the subgroup of participants without previous antihypertensive treatment but received no response |