Systolic Hypertension in Europe (Syst-Eur) Trial Phase 2: objectives, protocol, and initial progress

Abstract

The Systolic Hypertension in Europe (Syst-Eur) trial proved that blood pressure (BP) lowering therapy starting with nitrendipine reduces the risk of cardiovascular complications in older (⩾60 years) patients with isolated systolic hypertension (systolic BP ⩾160 mm Hg and diastolic BP <95 mm hg). after the completion of the syst-eur trial on 14 february 1997, 3506 consenting patients (93.0% of those eligible) were enrolled in phase 2 of the syst-eur trial. this open follow-up study aims to confirm the safety of long-term antihypertensive therapy based on a dihydropyridine. to lower the sitting systolic bp below 150 mm hg (target bp), the first-line agent nitrendipine (10–40 mg/day) may be associated with enalapril (5–20 mg/day), hydrochlorothiazide (12.5–25 mg/day), both add-on study drugs, or if required any other antihypertensive agent. on 1 november 1998, 3248 patients were still being followed, 86 patients had proceeded to non-supervised follow-up, and 43 had died. the median follow-up in syst-eur 2 was 14.3 months. at the last available visit, systolic/diastolic bp in the patients formerly randomised to placebo (n = 1682) or active treatment (n = 1824), had decreased by 13.2/5.2 mm Hg and by 4.6/1.6 mm Hg, respectively, so that the between-group BP difference was 1.7 mm Hg systolic (95% Cl: 0.8 to 2.6 mm Hg; P < 0.001) and 0.9 mm hg diastolic (95% cl: 0.4 to 1.5 mm mm hg; P < 0.001). at the beginning of syst-eur 2, the goal bp was reached by 25.4% and 50.6% of the former placebo and active-treatment groups; at the last visit these proportions were 55.9% and 63.1%, respectively. at that moment, 45.9% of the patients were on monotherapy with nitrendipine, 29.3% took nitrendipine in combination with other study drugs. until the end of 2001, bp control of the syst-eur 2 patients will be further improved. cardiovascular complications and adverse events, such as cancer or gastro-intestinal bleeding, will be monitored and validated by blinded experts.