Shell. Systolic hypertension in the elderly: lacidipine long term study.

The rise in systolic blood pressure (SBP) frequently observed in elderly patients (Pts) is no longer considered as a normal expression of the age-related increase in arterial stiffness, capable of preserving cerebral, coronary and renal blood flow. Isolated systolic hypertension (ISH) actually represents a risk factor for the development of cardiovascular complications such as heart failure, coronary artery disease and stroke. The Systolic Hypertension in the Elderly (SHELL) study is an on-going Italian trial (target 1600 Pts) conceived to evaluate the efficacy and tolerability of lacidipine (L) as compared to chlortalidone (C) in the treatment of ISH in elderly Pts. The primary aim of the study is to assess the incidence of cardio- and cerebrovascular events in ISH Pts during pharmacological treatment with either L or C. Moreover the potential role of L in reducing fatal myocardial events and total cardiovascular mortality is addressed. The study design consists of two parallel branches: a double-blind protocol, performed in a limited number of Pts for 1 year, to compare the anti-hypertensive effects of the two drugs; and an open protocol, lasting 36-60 months, aimed at evaluating differences in the incidence of cardio- and cerebrovascular events with the two treatments. Two other side projects - consisting of periodical echocardiographic evaluations and 24h blood pressure. recordings - have also been planned. Since the beginning of the study, in September 1993, 1019 Pts (369 M, 650 F) have been enrolled for the open protocol. Age was less than 80 years in 74% of Pts. Fifty-three percent showed SBP values higher than 180 mmHg. Preliminary data in 129 Pts treated with L and in 117 Pts treated with C after a 12 month follow-up show a decrease of SBP from 179±11 to 148±11 mmHg and from 180±11 to 144±13 mmHg, respectively.