THERAPY IN OLD PATIENTS WITH ISOLATED SYSTOLIC HYPERTENSION - 4TH PROGRESS REPORT ON THE SYST-EUR TRIAL

The Syst-Eur trial is a multicentre, randomized, double-blind, placebo controlled therapeutical trial in patients at least 60 years old and with isolated systolic hypertension. Its scope is to investigate the e ffects of modern antihypertensive drug treatment on morbidity and mort ality and to assess possible adverse effects of the drugs used. Patien ts were recruited in 22 countries in western and eastern Europe and Is rael. At three run-in visits 1 month apart their sitting systolic bloo d pressure (SEP) on single-blind placebo treatment averaged 160-219 mm Hg with diastolic blood pressure (DBP) lower than 95 mm Hg. After str atification for sex and the presence of cardiovascular complications, the patients were randomized either to active treatment or placebo. Ac tive treatment consisted of nitrendipine (10-40 mg/day) with the possi ble addition of enalapril (5-20 mg/day) and/or hydrochlorothiazide (12 .5-25 mg/day), titrated or combined to reduce the sitting SEP by at le ast 20 mm Hg to below 150 mm Hg. Matching placebos were employed simil arly. The present progress report is based on the data received at the Coordinating Office before 1 March 1996. At that time 3433 subjects h ad been randomized. A total of 2015 patients had been followed for at least 1 year on double-blind treatment and 1298 patients for at least 2 years. At baseline BP was similar in both treatment groups and avera ged 174/86 mm Hg. According to a per-protocol analysis at 1 year, BP f ell (P < 0.001) on average by 22.6 +/- 15.7/6.0 +/- 8.0 mm Hg in the a ctive treatment group and by 12.2 +/- 15.9/1.7 +/- 7.3 mm Hg in the pl acebo group. At 2 years BP was 10.2/5.7 mm Hg lower (P < 0.001) on act ive treatment than on placebo. At 1 year the percentage of patients wh o had reached goal BP was 19.9% in the placebo group and 41.4% in the active treatment group. At 2 years these percentages were 20.9 and 43. 2 respectively.