Characteristics of 9194 patients with left ventricular hypertrophy - The LIFE study

Losartan was the first available orally administered selective antagonist o f the angiotensin II type 1 receptor developed for the treatment of hyperte nsion. The Losartan Intervention For Endpoint (LIFE) Reduction in Hypertens ion Study is a double-blind, prospective, parallel group study designed to compare the effects of losartan with those of the beta-blocker atenolol on the reduction of cardiovascular morbidity and mortality. Patients with esse ntial hypertension, aged between 55 and 80 years, and EGG-documented left v entricular hypertrophy (LVH) were included. Altogether, 9223 patients in Sc andinavia, the United Kingdom, and the United States were randomized from J une 1995 through April 1997, and 9194 remain after exclusion of a study cen ter at which irregularities were discovered. This population of hypertensiv es (mean systolic/diastolic blood pressure, 174.4/97.8 mm Hg) with LVH comp rises women (54.1%) and men, mostly retired from active work (mean age, 66. 9 years), with a high prevalence of overweight (mean body mass index, 28.0 kg/m(2)), diabetes mellitus (12.3%), lipid disorders (18.0%), and symptoms or signs of coronary heart disease (15.1%). There were fewer current smoker s (<17%) than in the general population, and approximate to 7% were nonwhit e. Almost 30% of participants had been untreated for at least 6 months when screened for the study. Only 1557 persons who entered the placebo run-in p eriod of 14 days were excluded, predominantly because of sitting blood pres sures above or below the predetermined range of 160-200/95-115 mm Hg and EC G-LVH criteria not met. By application of simple 12-lead ECG criteria for L VH (Cornell voltage QRS duration product formula plus Sokolow-Lyon voltage read by a core laboratory), hypertensive patients with LVH with an average 5-year coronary heart disease risk of 22.3% according to the Framingham sco re were identified. This population is now being treated (goal, <140/90 mm Hg) in adherence with the protocol for at least 4 years after final enrollm ent (ie, through April 2001) and until at least 1040 patients suffer myocar dial infarction, stroke, or cardiovascular death.