Systolic Hypertension in Europe (Syst-Eur) Trial Phase 2: objectives, protocol, and initial progress
| Autor: | C Nachev, P. W. De Leeuw, Lutgarde Thijs, Y Yodfat, A E Fletcher, Christopher J. Bulpitt, M. Safar, K Kawecka-Jaszcz, J Webster, Robert Fagard, J Rosenfeld, GG Arabidze, Hilde Celis, Jan A. Staessen, J Duggan, J Tuomilehto, Jerzy Gasowski, W. H. Birkenhäger, JL Rodicio, M.-L. Seux, CT Dollery, G Leonetti |
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| Rok vydání: | 1999 |
| Předmět: |
medicine.medical_specialty
Systolic hypertension business.industry medicine.medical_treatment Dihydropyridine Diastole Calcium channel blockade Trial Phase medicine.disease Placebo Surgery Blood pressure Hydrochlorothiazide Nitrendipine Internal medicine Isolated systolic hypertension Internal Medicine medicine Cardiology Enalapril Diuretic business medicine.drug |
| Zdroj: | Journal of Human Hypertension. 13:135-145 |
| ISSN: | 1476-5527 0950-9240 |
| DOI: | 10.1038/sj.jhh.1000769 |
| Popis: | 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 (> or = 60 years) patients with isolated systolic hypertension (systolic BP > or = 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% Ci: 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. |
| Databáze: | OpenAIRE |
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