BACKGROUND:Hyperfibrinogenemia is a predictor of cardiovascular events in healthy subjects and in patients with chronic ischemic heart disease. Bezafibrate decreases fibrinogen levels and also the incidence of major cardiovascular events in primary prevention, but its effects in acute coronary syndrome are unknown. METHODS: This is a randomized, controlled clinical trial with conventional therapy. We included patients with Acute ST Elevation Myocardial Infarction (STEAMI) and fibrinogen concentration >500 mg/dl at 72 h of evolution. We randomized subjects into two groups: bezafibrate 400 mg (group I) and conventional therapy (group II). Primary end point was decrease of fibrinogen concentrations. Secondary end points were recurrence of angina or infarction, left ventricular failure and combined end points during hospitalization. RESULTS: We included 25 patients in each group. Fibrinogen concentrations were lower at hospital discharge in Group I than in Group II (532.42 +/- 129.6 vs. 889 +/- 127.32 mg/dl in group II, p <0.0001). Secondary end points were more frequent in Group II than in Group I: angina (56% vs. 4%, RR 0.071 [0.010-0.503], p <0.0001), left ventricular failure (24% vs. 4%, RR 0.167 [0.022-1.286], p = 0.049) and combined end points (76% vs. 8%, RR 0.105 [0.027-0.405], p <0.001). CONCLUSIONS:Bezafibrate treatment was a safe treatment and reduced fibrinogen levels in patients with STEAMI and hyperfibrinogenemia. In the short term, this reduction was associated with a lower incidence of major cardiovascular events.
RCT Entities:
BACKGROUND: Hyperfibrinogenemia is a predictor of cardiovascular events in healthy subjects and in patients with chronic ischemic heart disease. Bezafibrate decreases fibrinogen levels and also the incidence of major cardiovascular events in primary prevention, but its effects in acute coronary syndrome are unknown. METHODS: This is a randomized, controlled clinical trial with conventional therapy. We included patients with Acute ST Elevation Myocardial Infarction (STEAMI) and fibrinogen concentration >500 mg/dl at 72 h of evolution. We randomized subjects into two groups: bezafibrate 400 mg (group I) and conventional therapy (group II). Primary end point was decrease of fibrinogen concentrations. Secondary end points were recurrence of angina or infarction, left ventricular failure and combined end points during hospitalization. RESULTS: We included 25 patients in each group. Fibrinogen concentrations were lower at hospital discharge in Group I than in Group II (532.42 +/- 129.6 vs. 889 +/- 127.32 mg/dl in group II, p <0.0001). Secondary end points were more frequent in Group II than in Group I: angina (56% vs. 4%, RR 0.071 [0.010-0.503], p <0.0001), left ventricular failure (24% vs. 4%, RR 0.167 [0.022-1.286], p = 0.049) and combined end points (76% vs. 8%, RR 0.105 [0.027-0.405], p <0.001). CONCLUSIONS:Bezafibrate treatment was a safe treatment and reduced fibrinogen levels in patients with STEAMI and hyperfibrinogenemia. In the short term, this reduction was associated with a lower incidence of major cardiovascular events.
Authors: Alexander Tenenbaum; Diego Medvedofsky; Enrique Z Fisman; Liudmila Bubyr; Shlomi Matetzky; David Tanne; Robert Klempfner; Joseph Shemesh; Ilan Goldenberg Journal: PLoS One Date: 2012-04-16 Impact factor: 3.240