Single blind, multicentre, randomized, controlled trial testing the effects of a novel nutraceutical compound on plasma lipid and cardiovascular risk factors: Results of the interim analysis.

BACKGROUND AND AIMS: The clustering of high levels of LDL cholesterol (LDL-C) and other risk factors represents a predisposing condition for atherosclerotic disease development. Cardiovascular prevention is based on effective control of these conditions. In adult subjects with mild hypercholesterolemia we compared in the real life the effects of a new combination of nutraceuticals on lipid and glucose metabolism and blood pressure with those of an established nutraceutical combination. METHOD AND RESULTS: This multicenter, controlled, randomized, single-blind trial was designed to compare the effect of Armolipid Plus® versus that of LopiGLIK® on lipid and glucose levels and blood pressure (BP) in subjects with mild hypercholesterolemia not on statin therapy. Primary outcome was the proportion of subjects achieving therapeutic targets of LDL-C (<130 mg/dl); secondary outcomes were the effects on HDL-C, glycated haemoglobin and insulin levels. Data from an overall sample of 359 adult individuals (age 55.2 ± 11.1 years, women 57.7%, LDL-C 157.3 ± 22.6 mg/dl, HDL-C 50.7 ± 13.0 mg/dl) are reported. 72% of subjects treated with LopiGLIK® and 43% treated with Armolipid Plus® achieved the primary endpoint (p < 0.0001). Both treatments reduced plasma levels of total and LDL-C and triglycerides (p < 0.001 for all comparisons). The treatments also reduced systolic and diastolic blood pressure, plasma levels of glycated haemoglobin, insulin and HOMA index. The changes induced by LopiGLIK® in all these metabolic parameters were greater than those obtained with Armolipid Plus®. CONCLUSIONS: The present analysis shows that LopiGLIK® may represent a more effective tool for clinical management of CV risk factors in subjects with mild hypercholesterolemia.

Depression is associated with increased occurrence of left ventricle concentric geometry in older subjects independently of blood pressure levels.

BACKGROUND AND AIM: Depression is emerging as an independent risk factor for CV events, though mechanisms underlying this association are unknown. We investigated the relation between depression and LV hypertrophy (LVH) and LV structure in a group of elderly subjects. METHODS AND RESULTS: Three hundred seventy patients (mean age 79 ± 6 years) were enrolled. CV risk factors were assessed. Depression was defined as a score ≥ 6 on the 15-item Geriatric Depression Scale. On the basis of the presence of LVH and of LV relative wall thickness (RWT) 4 echocardiographic patterns of LV adaptation were defined: concentric LVH (LVH with increased RWT); eccentric LVH (LVH with normal RWT); concentric LV remodeling (no LVH with increased RWT); normal LV (no LVH with normal RWT). Prevalence of hypertension was approximately 86% and 24.7% had diabetes (n.s. depressed vs not depressed subjects). BP was comparable in these two groups (134.7 ± 1.4 vs 135.3 ± 1.8 mmHg, 77.1 ± 0.8 vs 76.3 ± 1.0 mmHg for SBP and DBP respectively). Depressed subjects (n = 165) showed a significantly higher occurrence of concentric LVH than not depressed, after adjustment for age, sex, and hypertension. Depression was associated with a 2.1 fold higher risk of showing a LV concentric, either remodeling or LVH, pattern after adjustment for age, sex, and traditional CV risk factors. CONCLUSIONS: Depression is accompanied by a higher occurrence of concentric LVH in elderly subjects, independently of BP levels.

[Survival of bone tissue in organotypic culture under intermittent mechanical loading. Preliminary results]. / Sopravvivenza del tessuto osseo in cultura organotipica, sotto carico meccanico intermittente. Risultati preliminari.

With the aim to study the mechanism of transduction of mechanical stimuli in biological ones we have realized an experimental device for the application of intermittent mechanical forces on bone specimens in vitro. The scheme of the device is reported in Fig. 1. It is constituted by a drive shaft which rotates on eccentric axis (1) supporting a longitudinal bar (2) with the load (3). The latter rests on a piston (4) only during a limited period of every shaft revolution, so that the load becomes intermittent. The bone specimen (5) is placed under the piston and the two are placed in a tube containing the culture medium. This latter is BGJ mod. Fitton-Jackson (Gibco), enriched with fetal calf serum (10%) and ascorbic acid (70 microliters/ml). Right metatarsi from 18-day-old rats were removed aseptically and placed under the piston for 2-6 days after resection of both ends. The homotypic ones, unloaded, were placed in 30 mm Petri dishes, and used as a control. The incubator environment was 5% CO2 in air (A group), or enriched with O2 (25-35%) (B group). At the end of the experimental period the bone specimens were fixed in 4% formalin buffered and treated for conventional histologic methods. In the A group most of the osteocytic lacunae were empty. The osteoblasts disappeared already at the 2nd day; the periosteal fibroblast dedifferentiated and multiplied. The deposition or calcification of osteoid were completely lacking. The application of mechanical load promoted deposition of granular degenerative material around the bone, and the periosteal cells, well differentiated, were surrounded by metachromatic material, which resembles cartilage matrix.(ABSTRACT TRUNCATED AT 250 WORDS)