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Marco Righetti, Gian Michele Ferrario, Silvana Milani, Paola Serbelloni, Lucia La Rosa, Mario Uccellini, Adalberto Sessa
Med Sci Monit 2003; 9(4): PI19-24
BACKGROUND: Cardiovascular disease is the most important cause of morbidity and mortality in hemodialysis patients. These patients frequently have hyperhomocysteinemia, a putative risk factor for cardiovascular disease. Treatment with folate, B[sub]6[/sub] and B[sub]12[/sub] partially reduces hyperhomocysteinemia. We conducted a long-term study to evaluate whether 15 mg is more effective than 5 mg oral folic acid as a daily dosage to decrease hyperhomocysteinemia, and to assess whether homocysteine-lowering treatment reduces the risk of cardiovascular disease in hemodialysis patients. MATERIAL/METHODS: In a 1-year prospective randomised trial, 81 chronic hemodialysis patients, matched for age, gender and dialytic age, were divided into three groups: 30 untreated patients, 26 patients receiving 5 mg per day, and 25 patients receiving 15 mg per day. RESULTS: There was a significant reduction in hyperhomocysteinemia over time in treated patients as compared to untreated, but there were no significant differences between the two treated groups. Only 12% of the treated patients reached normal total homocysteine plasma levels. We observed a trend towards a significant difference in survival rate in cardiovascular morbidity between treated and untreated patients. Furthermore, hemodialysis patients with new vascular events showed higher homocysteine levels than patients without events. CONCLUSIONS: High-dose folic acid treatment did not improve outcome in hyperhomocysteinemia, and 88% of treated patients maintained higher than normal homocysteine levels. There was a trend towards a decreased rate of cardiovascular events in treated participants as compared to untreated ones.