Evaluating the benefits of an antihypertensive agent using trials based on event and organ damage: the Systolic Hypertension in the Elderly Long-term Lacidipine (SHELL) trial and the European Lacidipine Study on Atherosclerosis (ELSA).
Author(s): Zanchetti A
Affiliation(s): Istituto di Clinica Medica e Terapia Medica and Centro di Fisiologia Clinica e Ipertensione, Universita di Milano, Italy.
Publication date & source: 1995-12, J Hypertens Suppl., 13(4):S35-9.
Publication type: Clinical Trial; Controlled Clinical Trial; Review
AIMS: To assess the benefits of the calcium antagonist lacidipine on the prevention of cardiovascular events and the prevention of organ damage in two long-term clinical trials. SYSTOLIC HYPERTENSION IN THE ELDERLY LONG-TERM LACIDIPINE (SHELL) TRIAL: In the SHELL trial, the efficacy of lacidipine-based treatment is to be compared with that of thiazide-like diuretic (chlorthalidone)-based treatment in elderly patients with isolated systolic hypertension. The incidence of cardiovascular mortality and cardiovascular morbidity over a 5-year period are endpoints. EUROPEAN LACIDIPINE STUDY ON ATHEROSCLEROSIS (ELSA) TRIAL: In the ELSA trial, the effects of lacidipine-based treatment and beta-blocker (atenolol)-based treatment on the development and progression of carotid atherosclerosis are to be assessed in hypertensive patients. The primary endpoint of this study is the rate of change in the thickness of the carotid artery wall, measured with B-mode ultrasound.
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