Metabolic syndrome and left ventricular hypertrophy in a general population. Results from the Gubbio Study.

Aims of this study were to investigate the prevalence of metabolic syndrome (MS), diagnosed according to the International Diabetes Federation (IDF) criteria and its relationship with echocardiographic parameters of cardiac structure and function. The study was performed in 707 subjects, age 45-54 years, of the Gubbio Population Study who underwent a comprehensive examination including measurement of body size, blood pressure (BP) and heart rate, 12-lead electrocardiogram, Doppler echocardiography, standardized blood and urine laboratory tests. One hundred and fifty-three subjects were found to have MS, which was more frequent among hypertensive patients than normotensive controls (36.2 vs 13.7%, P<0.001). Apart from visceral obesity present in all subjects by definition according to the IDF criteria, high levels of BP (>130/85 mm Hg) and triglycerides (>or=150 mg/dl) were the most frequently observed components of the syndrome, since their prevalence averaged 75% of those with the syndrome. Left ventricular mass (95.6+/-22 vs 86.4+/-22 g/m(2); P<0.001) and prevalence of left ventricular hypertrophy were increased in the subgroup with MS. Waist circumference, BP and blood glucose were the components of the syndrome with stronger impact on cardiac mass. An early impairment of the diastolic function was detected in this subgroup with a reduction of the early-to-late diastolic filling (0.91+/-0.17 vs 0.99+/-0.23, P<0.001). The results of the present study indicate that MS is frequent in middle-aged general population, particularly in subjects with arterial hypertension. The syndrome is associated to the increase in ventricular mass and the early impairment of diastolic function.

Arterial hypertension increases left ventricular mass: role of tight blood pressure control.

In middle-age hypertensives from the Gubbio Population Study, we evaluated the relationship between blood pressure (BP) control over a long time and the prevalence of left ventricular hypertrophy (LVH). A population survey was performed in 1982-1985 and repeated in 1989-1992. During the second survey, subjects in the age range 40-60 years were invited to undergo an M-mode echocardiographic examination. A total of 487 subjects who participated in both surveys are included in the present analysis. Some of them (294) were normotensive (Group 1), 110 were hypertensive but had never taken antihypertensive drugs (Group 2), 47 hypertensives on drugs were in good BP control (Group 3) and 36 hypertensives on drugs had uncontrolled hypertension (Group 4). BP values at the 1989-1992 examination were, respectively, 122/77, 145/86, 124/78 and 153/91 mmHg, while 7 years earlier were 122/77, 133/84, 136/85 and 152/95 mmHg. Despite normal BP levels in Group 3, left ventricular mass index (LVMi, g/m(2.7)) was greater than in normotensives (42.4+/-10, 46.6+/-13, 47.0+/-10, 51.9+/-15 g/m(2.7)). Accordingly, the prevalence of LVH (LVMi >51 g/m(2.7)) was 18, 26.4, 36.7 and 50% in groups 1-4, respectively. The 193 hypertensives were, thereafter, divided according to BP control (ie <140/90 mmHg) on both surveys (1983-1985 and 1989-1992): 27 hypertensives with optimal BP levels on both visits also had a ventricular mass similar to normotensives and significantly lower than the other hypertensives (LVMi 44.6+/-11.6 vs 48.5+/-13.2, P<0.001). In conclusion, these findings indicate that hypertensive patients with BP values at levels similar to those in normotensives for a long period do not increase their left ventricular mass in comparison to subjects with normal BP levels.

Is there a relationship between left ventricular mass and plasma glucose and lipids independent of body mass index? Results of the Gubbio Study.

BACKGROUND AND AIMS: The association between left ventricular (LV) mass (M) and variables described as features of the insulin resistance syndrome, such as obesity and measures o lipid and carbohydrate metabolisms, has been reported in hypertensives. The aim of the present study was to investigate in a large, population based group of non hypertensive people, the prevalence of LV hypertrophy (H) and the relationship of LVM with some of the variables described in the insulin resistance syndrome, independently of obesity. For this reason we investigated the normotensive subjects in the age range 45-54 yrs (n = 435) of the total population of participants in the Gubbio Population Study. METHODS AND RESULTS: Serum lipids, cholesterol (Chol), triglyceride (Tg), HDL cholesterol, fasting blood glucose (FBG), blood pressure (BP), body weight and height were measured and body mass index (BMI) was calculated; LVM was assessed by M-mode echocardiography. Using a normalization criterion not related to body weight (g/m2.7) and the cut-off of 49.2 g/m2.7 for men and 46.7 g/m2.7 for women, LVH was found in 25% of the sample whilst, when LVM was corrected by body surface area (cut-off 116 g/m2 for men and 104 g/m2 for women), the prevalence of LVH was quite lower (10.3%). In the univariate analyses LVMi was closely related to BP, BMI and metabolic variables whilst in the multivariate analysis only BP, BMI, and age were detected as independent predictors of LVMi. When the sample was divided into obese and non-obese subjects on the basis of BMI (cut-off 30 kg/m2), no difference in metabolic variables was seen between subjects with and without LVH within each BMI class. Regarding left ventricular geometry, RWT was positively related to triglycerides and blood glucose and inversely to HDL-chol. CONCLUSIONS: The present study in the middle age normotensive sample of the general population of Gubbio extends to normotensives the relationship between left ventricular mass and metabolic parameters already seen in hypertensives. BMI seems to account for most of the increases in LVM since the prevalence of LVH, which was definitely high when LVM was not normalized to body weight, fell to approximately 4% when the influence of body weight was excluded. Moreover differences in metabolic values between subjects with and without LVH disappeared when the subjects were stratified by BMI. Left ventricular geometry, on the other hand, seems to be related to some metabolic variables.

Combined therapy with benazepril and amlodipine in the treatment of hypertension inadequately controlled by an ACE inhibitor alone.

In a multicenter, randomized, double-blind, placebo-controlled study, we evaluated the efficacy and tolerability of the combination of benazepril, 10 mg, and amlodipine, 2.5 or 5 mg once daily, compared with benazepril, 10 mg, monotherapy in patients with hypertension inadequately controlled with angiotensin-converting enzyme (ACE)-inhibitor monotherapy. After a 2-week placebo and 4-week single-blind benazepril, 10 mg once daily, run-in period, 448 patients, 213 men and 235 women, aged 24-73 years (mean, 55 years), with mean diastolic blood pressure (DBP) > or =95 and < or =120 mm Hg at the end of the benazepril run-in period, were randomized to receive one of the following treatments once daily for 8 weeks: (a) benazepril, 10 mg, plus placebo (BZ10); (b) benazepril, 10 mg, plus amlodipine, 2.5 mg (BZ10/AML2.5); or (c) benazepril, 10 mg, plus amlodipine, 5 mg (BZ10/AML5). Before the patients were admitted to the trial, at the end of the placebo run-in and the benazepril run-in period and at the end of weeks 4 and 8 of the treatment period, sitting and standing blood pressure (BP), heart rate (HR), and body weight were measured 22-26 h after the intake of the trial medication. Both BZ10/AML2.5 and BZ10/AML5 combinations showed better antihypertensive activity than did BZ10 monotherapy at the terminal visit as demonstrated by (a) the 24-h postdosing sitting and standing systolic BP (SBP) and DBP values, which were statistically lower with combination therapy than with BZ10; (b) the success rate, which was statistically higher with both the combinations (69.2% in the BZ10/AML2.5 and 65.8% in the BZ10/AML5 group) compared with the BZ10 group (40.5%). The tolerability was good in the three treatment groups. No significant abnormal laboratory data were detected. There was no difference in efficacy and safety/tolerability between the BZ10/AML2.5 and BZ10/AML5 groups.

Valsartan, a new angiotensin II antagonist for the treatment of essential hypertension: a comparative study of the efficacy and safety against amlodipine.

OBJECTIVE: To compare the antihypertensive efficacy of a new angiotensin II antagonist, valsartan, with a reference therapy, amlodipine. METHODS: One hundred sixty-eight adult outpatients with mild to moderate hypertension were randomly allocated in double-blind fashion and equal number to receive 80 mg valsartan or 5 mg amlodipine for 12 weeks. After 8 weeks of therapy, in patients whose blood pressure remained uncontrolled, 5 mg amlodipine was added to the initial therapy. Patients were assessed at 4, 8, and 12 weeks. The primary efficacy variable was change from baseline in mean sitting diastolic blood pressure at 8 weeks. Secondary variables included change in sitting systolic blood pressure and responder rates. RESULTS: Both valsartan and amlodipine were effective at lowering blood pressure at 4, 8, and 12 weeks. Similar decreases were observed in both groups, with no statistically significant differences between the groups for any variable analyzed. For the primary variable the difference was 0.5 mm Hg in favor of valsartan (p = 0.68; 95% confidence interval, -2.7 to 1.7). Responder rates at 8 weeks were 66.7% for valsartan and 60.2% for amlodipine (p = 0.39). Both treatments were well tolerated. The incidence of drug-related dependent edema was somewhat higher in the amlodipine group, particularly at a dose of 10 mg per day (2.4% for 80 mg valsartan; 3.6% for 5 mg amlodipine; 0% for valsartan plus 5 mg amlodipine; 14.3% for 10 mg amlodipine). CONCLUSIONS: The data show that valsartan is at least as effective as amlodipine in the treatment of mild to moderate hypertension. The results also show valsartan to be well tolerated and suggest that it is not associated with side effects characteristic of this comparator class, dihydropyridine calcium antagonists.