BASE-LINE CHARACTERISTICS OF PARTICIPANTS IN THE APPROPRIATE BLOOD-PRESSURE CONTROL IN DIABETES TRIAL

Citation
Ro. Estacio et al., BASE-LINE CHARACTERISTICS OF PARTICIPANTS IN THE APPROPRIATE BLOOD-PRESSURE CONTROL IN DIABETES TRIAL, Controlled clinical trials, 17(3), 1996, pp. 242-257
Citations number
32
Categorie Soggetti
Medicine, Research & Experimental","Pharmacology & Pharmacy
Journal title
ISSN journal
01972456
Volume
17
Issue
3
Year of publication
1996
Pages
242 - 257
Database
ISI
SICI code
0197-2456(1996)17:3<242:BCOPIT>2.0.ZU;2-#
Abstract
The ABCD (Appropriate Blood Pressure Control in Diabetes) trial is a l arge, prospective, randomized clinical trial designed to compare the e ffects of intensive with moderate blood pressure control on the preven tion and progression of diabetic nephropathy, retinopathy, cardiovascu lar disease, and neuropathy in non-insulin-dependent diabetes (NIDDM). The secondary objective is to determine equivalency of the effects of a calcium channel blocker (nisoldipine) and of an angiotensin-convert ing enzyme inhibitor (enalapril) as a first-line antihypertensive agen t in the prevention and/or progression of these diabetic vascular comp lications. The study consists of two study populations: a hypertensive one (diastolic blood pressure of greater than or equal to 90.0 mm Hg at the time of randomization) and a normotensive one (diastolic blood pressure of 80.0-89.0 mm Hg at the time of randomization). A total of 950 men and women aged 40-74 years were randomized and are being follo wed for 5 years at a single center. There were 470 randomized particip ants in the hypertensive population and 480 randomized participants in the normotensive population. This report summarizes the demographic, biochemical, and clinical characteristics of the randomized patients a t the time of entry into the trial and evaluates the balance between t he treatment groups within each population.