Medical & Clinical Research

Author(s): MR Cesarone, G BELCARO*, M Dugall1 M Hosoi, S Hu U Cornelli, P Morazzoni, A Ledda, L Pellegrini, D Cox B Feragalli1,4 and R Cotellese

This registry evaluates the effect of ECOVITIS™ (grape seeds extract) in borderline hypertension (also evaluating endothelialmediated vasodilatation). The main targets of the registry were the normalization of blood pressure and of an altered endothelial function (EF); 3 groups of 15 subjects used: Standard Management (SM) (GROUP 1); GROUP 2: SM+ECOVITIS™ (150 mg/day); GROUP 3: SM+ECOVITIS™ (300 mg/day).

Results. The groups were comparable. Tolerability/safety were optimal. Blood tests, urines and ECG were normal at 4 and 12 weeks. BMI showed, minimal variations (<26) in 3 months. Blood pressure (systolic, diastolic) and heart rate indicate a progressive improvement in Group 3 (p<0.05) with better values at 4 and 12 weeks. The lower dose improved (p<0.05) blood pressure and heart rate better than SM. Lipids and oxidative stress were improved better with the high dose (p<0.05). The lower dose resulted better than SM (<0.05). Other metabolic parameters (blood sugar and glycosylated hemoglobin) followed the same patterns (Group 3 resulted better that the other two groups) (p<0.05). Laser Doppler measurements (skin flux) and strain gauge plethysmography measured an improvement in post-occlusive flow (EF) at the level of the arm (p<0.65). This was confirmed by artery ultrasound measurements showing a larger increase in size in the brachial artery after occlusion with ECOVITIS TM (subjects in Group 3 had the best results (p<0.025); the lower dose (Group 2) was superior to SM (p<0.05). Tc PO2 increased more in group 3 (p<0.05); PCO2 was decreased. Results in the lower dose group were better (p<0.05) than results in the SM patients.

In conclusion, this pilot registry shows that ECOVITIS™ is safe, well tolerated and may control and improve blood pressure and EF in borderline subjects. More studies may be needed for a longer period of time.