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

The Systolic Hypertension in Europe (Syst-Eur) trial proved that blood pres sure (BP) lowering therapy starting with nitrendipine reduces the risk of c ardiovascular complications in older (greater than or equal to 60 years) pa tients with isolated systolic hypertension (systolic BP greater than or equ al to 160 mm Hg and diastolic BP <95 mm Hg). After the completion of the Sy st-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 b ased 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 assoc iated with enalapril (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), b oth 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-u p in Syst-Eur 2 was 14.3 months. At the last available visit, systolic/dias tolic BP in the patients formerly randomised to placebo (n = 1682) or activ e treatment (n = 1824), had decreased by 13.2/5.2 mm Hg and by 4.6/1.6 mm H g, respectively, so that the between-group BP difference was 1.7 mm Hg syst olic (95% CI: 0.8 to 2.6 mm Hg; P < 0.001) and 0.9 mm Hg diastolic (95% CI: 0.4 to 1.5 mm mm Hg; P < 0.001). At the beginning of Syst-Eur 2, the goal BE was reached by 25.4% and 50.6% of the former placebo and active-treatmen t groups; at the last visit these proportions were 55.9% and 63.1%, respect ively. At that moment, 45.9% of the patients were on monotherapy with nitre ndipine, 29.3% took nitrendipine in combination with other study drugs;. Un til the end of 2001, BP control of the Syst Eur 2 patients will be further improved. Cardiovascular complications and adverse events, such as cancer o r gastro-intestinal bleeding, will be monitored and validated by blinded ex perts.