Simvastatin and supplementation with ω-3 polyunsaturated fatty acids and vitamins improves claudication distance in a randomized PILOT study in patients with peripheral vascular disease

Peripheral vascular disease (PVD) is a manifestation of systemic atherosclerosis. Statins and a number of nutrients are effective in controlling the risk for cardiovascular disease. We hypothesized that a combined intervention of a selection of nutrients together with simvastatin could ameliorate the risk factors and clinical symptoms in these patients. A 12-month longitudinal, randomized, controlled pilot study was conducted in which 40 male PVD patients with intermittent claudication were allocated into 4 intervention groups. Group S was provided with 500 mL/d of a fortified dairy product containing fish oil, oleic acid, folic acid, and other vitamins. Group SS consumed the same fortified product plus 20 mg/d of simvastatin. Group C was provided with 500 mL/d of semiskimmed milk, and group CS received semiskimmed milk plus simvastatin. Every 6 months, blood collections and clinical examinations were performed. Groups S and SS tripled their claudication distance (P < .001), and group SS increased ankle-brachial index (P < .05). Group S and SS increased their plasma levels of folate, eicosapentaenoic, docosahexaenoic, and oleic acids (P < .05) and decreased their homocysteine concentration (P < .05). In addition, group C had increased total and low-density lipoprotein cholesterol concentrations (P < .05). In the groups that consumed the nutritional supplement, the increase in claudication distance correlated with the increase of plasma docosahexaenoic acid (r = 0.40; P < .05). These results suggest that the combination of hypolipidemic therapy and a daily consumption of cardioprotective nutrients could be effective in PVD management. Moreover, this pilot study suggests that nutrients per se might play a major role in producing the benefits observed. Further studies are needed to clarify the potential role of nutritional interventions in PVD progression and management.