Systolic hypertension in the elderly: long-term lacidipine treatment. Objective, protocol, and organization. SHELL Study Group.

Isolated systolic hypertension (ISH) is a definite risk factor for cardiovascular complications (i.e., cardiac failure, coronary artery disease, and stroke) independent of diastolic elevation. The prevalence of ISH is estimated to be approximately 15-20% in the population above the age of 60 years, and increases with advancing age. The Systolic Hypertension in the Elderly (SHELL) study is planned to evaluate the efficacy and tolerability of lacidipine, matched with the diuretic chlorthalidone, in treatment of ISH in elderly hypertensive patients (EHP). One hundred fifteen Italian centers will participate in the study. Fifty centers are associated with the Società Italiana di Geriatria Ospedaliera and 65 centers are departments of internal medicine or outpatient clinics for management of hypertension. A total of 4,800 patients will be enrolled in the trial. Two subprojects will consist of periodical echocardiographic evaluation and 24-h ambulatory blood pressure monitoring. The primary end point of the SHELL study is the incidence of cardiovascular and cerebrovascular events in EHP with ISH, treated with either lacidipine or chlorthalidone. In particular, the SHELL trial is intended to determine whether lacidipine treatment will significantly reduce fatal myocardial events and total cardiovascular mortality.

Evening vs morning isradipine sustained release in essential hypertension: a double-blind study with 24 h ambulatory monitoring.

A randomized, double-blind, placebo controlled study evaluated the effects on 24 h ambulatory blood pressure (ABP) of isradipine sustained release (I-SRO) administered once daily, in the morning (AM) or in the evening (PM). Eighteen uncomplicated essential hypertensives (10 men, mean age 55 +/- 6 years) with casual sitting DBP 96-110 mm Hg received, according to a triple-way crossover design, I-SRO 5 mg AM, or 5 mg PM, or placebo for 4 weeks. A 24 h ABP monitoring (Spacelabs 90207) was carried out at the end of each treatment. Twenty-four hour BP was 145.3/89.8 mm Hg after randomized placebo. AM and PM I-SRO significantly reduced 24 h BP, by 13.7/8.7 and 12.9/8.2 mm Hg respectively. Daytime (07.00 h-23.00 h) BP significantly decreased by 15.0/9.7 mm Hg with AM and 13.2/8.7 mm Hg with PM regimen; night-time BP (23.00 h-07.00 h) significantly decreased by 11.6/7.1 and 12.3/7.4 mm Hg, respectively. Nocturnal nadir BP values were 132.6/78.1 after randomized placebo, 120.9/71.4 after AM I-SRO and 121.0/72.4 mm Hg after PM I-SRO. Morning peak BP values were 154.6/96.9, 139.5/87.6 and 137.5/85.5 mm Hg, respectively. Mean BP values in the early morning hours (i.e. between 03.00 h and 08.00 h) were significantly decreased by 12.1/7.3 mm Hg after AM and 14.3/7.9 mm Hg after PM intake. No significant differences were detected in the BP lowering effect of the two I-SRO regimens.(ABSTRACT TRUNCATED AT 250 WORDS)