RANDOMIZED DOUBLE-BLIND COMPARISON OF PLACEBO AND ACTIVE TREATMENT FOR OLDER PATIENTS WITH ISOLATED SYSTOLIC HYPERTENSION

Background Isolated systolic hypertension occurs in about 15% of peopl e aged 60 years or older. In 1989, the European Working Party on High Blood Pressure whether active treatment investigated cardiovascular co mplications hypertension. Fatal and non-fatal stroke combined was the primary endpoint. Methods All patients (greater than or equal to 60 ye ars) were initially started on masked placebo. At three run-in visits 1 month apart, their average sitting systolic blood pressure was 160-2 19 mm Hg with a diastolic blood pressure lower than 95 mm Hg. After st ratification for centre, sex, and previous cardiovascular complication s, 4695 patients were randomly assigned to nitrendipine 10-40 mg daily , with the possible addition of enalapril 5-20 mg daily and hydrochlor othiazide 12.5-25.0 mg daily, or matching placebos. Patients withdrawi ng from double-blind treatment were still followed up. We compared occ urrence of major endpoints by intention to treat. Findings At a median of 2 years' follow-up, sitting systolic acid diastolic blood pressure s had fallen by 13 mm Hg and 2 mm Hg in the placebo group (n=2297) and by 23 mm Hg and 7 mm Hg in the active treatment group (n=2398). The b etween-group differences were systolic 10.1 mm Hg (95% CI 8.8-11.4) an d diastolic, 4.5 mm Hg (3.9-5.1). Active treatment reduced the total r ate of stroke from 13.7 to 7.9 endpoints per 1000 patient-years (42% r eduction; p=0.003). Non-fatal stroke decreased by 44% (p=0.007). In th e active treatment. group, all fatal and non-fatal cardiac endpoints, including sudden death, declined by 26% (p=0.03). Non-fatal cardiac en dpoints decreased by 33% (p=0.03) and all fatal and non-fatal cardiova scular endpoints by 31% (p<0.001). Cardiovascular mortality was slight ly lower on active treatment (-27%, p=0.07), but all-cause mortality w as not influenced (-14%; p=0.22). Interpretation Among elderly patient s with isolated systolic hypertension, antihypertensive drug treatment starting with nitrendipine reduces the rate of cardiovascular complic ations. Treatment of 1000 patients for 5 years with this type of regim en may prevent 29 strokes or 53 major cardiovascular endpoints.