Although the role of homocysteine (HCys) in secondary cardiovascular prevention has been scaled down, hyper-homocysteinemia remains – like hypertension – a risk factor for cerebrovascular events. Primary cardiovascular and cerebrovascular prevention may be achieved by lifestyle/nutrition changes, although a relevant role is emerging for nutraceutical compounds. The aim of this study was to investigate the efficacy of nutraceuticals in lowering HCys serum levels versus a conventional vitamins supplementation in hypertensive subjects at low cardiovascular risk.Design and method:
One-hundred and four patients (mean age 62.0 ± 13.7 years, 69% males), 52 for each treatment group, were enrolled. The study enrolled patients with grade-1 essential hypertension and hyper-homocysteinemia (HCys > = 15 mcmol/L), and without history of cardiovascular and cerebrovascular disease. They were randomized to receive, for 2 months, the nutraceutical Normocis400 once-daily (containing 400 mcg folate-6-5-methyltetrahydrofolate, 3 mg vitamin B6, 5 mcg vitamin B12, 2.4 mg vitamin B2, 12.5 mg zinc and 250 mg bethaine), or free supplementation with folic acid and/or vitamin B complex at dosages commonly available (control group). Differences in serum HCys values were compared by ANOVA for repeated measures.Results:
A significant HCys reduction in comparison to baseline was found in both groups at the end of study treatment, from 21.5 ± 8.7 to 10.0 ± 1.7 for Normocis400 (p < 0.0001), and from 22.6 ± 6.2 to 14.3 ± 2.8 for controls (p < 0.0001). HCys reduction was significantly higher among patients treated Normocis400 (p < 0.035, Figure 1). The ideal HCys level (i.e. <10 mcmol/L) was reached in 33.7% of cases in the Normocis400 group, and it was significantly higher than in controls (Figure 2). No side effects were observed in both treatment groups.Conclusions:
Randomized clinical trials are ongoing to test the effect of folate, B6, and B12 supplementation in primary prevention of cardiovascular and cerebrovascular events. Up to date, there are no clear recommendations for the treatment of hyper-homocysteinemia. In the meantime, even when the ideal HCys level is far from being reached, Normocis400 appears to be safe, well tolerated and effective in reducing HCys levels.