Table III.
Clinical trials relevant to the secondary prevention of stroke at any age, or prevention of stroke in the oldest patients with cardiovascular risk factor modification
| Name | Population | Treatment | Key clinical findings |
|---|---|---|---|
| Hypertension | |||
| PROGRESS[17] | 6105 hypertensive and non-hypertensive patients with a history of stroke of any cause or TIA (mean age 64 years; SD 10 years) | β-Adrenoceptor antagonist ± diuretic vs placebo | Antihypertensive therapy resulted in an ARR of 3.7% for stroke (10.1% vs 13.8% ; p < 0.0001) and 4.8% for vascular events (15.0% vs 19.8% ; p < 0.0001) compared with placebo; dual therapy with a β-adrenoceptor antagonist and diuretic was superior to monotherapy with a β-adrenoceptor antagonist |
| STOP- Hypertension[18] | 1627 hypertensive patients aged 70–84 years | 3 β-adrenoceptor antagonists + 1 diuretic vs placebo | Antihypertensive therapy reduced the number of primary endpoint eventsa by 36 (58 vs 94; p = 0.0031), fatal and non-fatal strokes by 24 (29 vs 53; p = 0.0081) and total deaths by 27 (36 vs 63; p = 0.0079) compared with placebo |
| SHEP[19] | 4736 patients aged ≥60 years (mean 72 years) with systolic hypertension | β-Adrenoceptor antagonist + diuretic vs placebo | Antihypertensive therapy resulted in an ARR of 2.0% (3.6% vs 5.6%) |
| HYVET (pilot study)[20] | 1283 hypertensive patients aged ≥80 years (mean age 83.8 years; range 79.5–96.1 years) | Diuretic vs β-adrenoceptor antagonist vs placebo | Antihypertensive therapy prevented 19 strokes but resulted in 20 additional non-stroke deaths per 1000 patients per year |
| HYVET[21] | 3845 hypertensive patients aged ≥80 years (mean age 83.6 ± 3.2 years for active treatment, 83.5 ± 3.1 years for placebo) | Indapamide vs placebo | Treating 1000 patients with indapamide for 2 years would prevent 11 strokes (95% CI 0, 21) |
| Dyslipidaemia | |||
| HPS[22] | 20 536 patients aged 40–80 years with a history of cerebrovascular disease (mean age 65.5 years; SD 7.8) or other arterial occlusive disease (mean age 63.7 years; SD 8.5) | Simvastatin vs placebo | In the 3280 patients with pre-existing cerebrovascular disease, simvastatin did not significantly reduce the absolute risk for stroke (10.3% vs 10.4%), but did reduce the absolute risk of having a major CVE by 5.1% (24.7% vs 29.9% ; p = 0.001) |
| SPARCL[23] | 4731 patients aged ≥18 years of age with hyperlipidaemia, no known CHD and a history of stroke or TIA in the previous 1–6 months (mean age 62.5 years; SD 0.2 years) | Atorvastatin vs placebo | Treatment with atorvastatin resulted in a 2.2% ARR for stroke (p = 0.03) and a 3.5% ARR for a major CVE (p = 0.002) |
| PROSPER[24] | 5804 patients aged 70–82 years with a history of, or risk factors for, vascular disease | Pravastatin vs placebo | Allocation to pravastatin resulted in an ARR of 2.1% (14.1% vs 16.2% ; p = 0.014) compared with placebo for the primary endpoint of CHD death, non-fatal MI, non-fatal stroke |
| Retrospective analysis of 50 clinical trials[25] | 5924 persons aged ≥65 years (mean age range 71–74 years) enrolled in the Pfizer Atorvastatin Clinical Program Database | Atorvastatin vs placebo | The rate of having at least one adverse event was similar among patients taking 4 different doses of atorvastatin (10.2–16.1%) and placebo (15.0%) and the number of serious adverse events was low (≤1.0%) |
a
Stroke, MI or cardiovascular death.
ARR = absolute risk reduction; CHD = coronary heart disease; CVE = cardiovascular event; MI = myocardial infarction; SD = standard deviation; TIA = transient ischaemic attack.