Sinzinger H, Pirich C, Kondor P, Etti H
Wilhelm Auerswald Atherosclerosis Research Group for the BLAU Study Group, Vienna, Austria.
Eur Heart J. 1995 Nov;16(11):1491-501. doi: 10.1093/oxfordjournals.eurheartj.a060769.
To examine the atherogenic risk-reducing effect of bezafibrate and lovastatin.
DESIGN, SETTING, PATIENTS, INTERVENTIONS: Double-blind, randomized clinical trial of male and female patients with moderate hypercholesterolaemia with or without hypertriglyceridaemia. Two months dietary treatment followed by 400 mg sustained release bezafibrate every day or 20 mg lovastatin every day for 6 months. Patients recruited (n = 561) and treated (n = 524) by primary care physicians throughout Austria.
Multifactorial assessment of atherogenic risk profile.
Bezafibrate increased high density lipoprotein cholesterol by 16%, lovastatin by 10% (P < 0.05). Bezafibrate decreased low density lipoprotein cholesterol by 20%, lovastatin by 27% (P < 0.001). Bezafibrate decreased total cholesterol by 15%, lovastatin by 18% (P < 0.001). Bezafibrate reduced triglycerides by 29%, lovastatin by 13% (P < 0.001); and fibrinogen by 9.4% and 3.0%, respectively. Fibrinogen reduction as a result of bezafibrate administration was dependent on starting levels. The risk ratio cholesterol:high density lipoprotein cholesterol (baseline both 6.1) reduction was 27% in both groups. The low:high density lipoprotein ratio (baseline: 4.1/4.2) reduction reached 31% and 34% respectively. Coronary events' probability (calculated from multifactorial risk functions) were greatly reduced by both agents (41%/33%). Hypertriglyceridaemic patients had a higher initial global coronary risk and profited more from treatment. Bezafibrate was significantly better tolerated (P < 0.001) than lovastatin; most events were gastrointestinal (6 vs 14, ns) or as a result of creatine phosphokinase elevations (3 vs 12, P < 0.05).
Both treatments significantly reduced the risk parameters for developing coronary heart disease, and calculated multifactorial coronary risk was similarly decreased. When selecting a drug for moderate dyslipidaemia and if haemostatic regulation is disturbed, the additional effect of bezafibrate on elevated fibrinogen levels should be considered.
研究苯扎贝特和洛伐他汀降低动脉粥样硬化风险的作用。
设计、地点、患者、干预措施：对患有中度高胆固醇血症伴或不伴高甘油三酯血症的男性和女性患者进行双盲、随机临床试验。先进行两个月的饮食治疗，随后每天服用400毫克缓释苯扎贝特或每天服用20毫克洛伐他汀，持续6个月。奥地利各地的初级保健医生招募（n = 561）并治疗（n = 524）患者。
对动脉粥样硬化风险概况进行多因素评估。
苯扎贝特使高密度脂蛋白胆固醇升高16%，洛伐他汀使高密度脂蛋白胆固醇升高10%（P < 0.05）。苯扎贝特使低密度脂蛋白胆固醇降低20%，洛伐他汀使低密度脂蛋白胆固醇降低27%（P < 0.001）。苯扎贝特使总胆固醇降低15%，洛伐他汀使总胆固醇降低18%（P < 0.001）。苯扎贝特使甘油三酯降低29%，洛伐他汀使甘油三酯降低13%（P < 0.001）；苯扎贝特和洛伐他汀分别使纤维蛋白原降低9.4%和3.0%。服用苯扎贝特导致的纤维蛋白原降低取决于起始水平。两组胆固醇：高密度脂蛋白胆固醇（基线均为6.1）的风险比降低均为27%。低密度脂蛋白：高密度脂蛋白比值（基线：4.1/4.2）的降低分别达到31%和34%。两种药物均大幅降低了冠状动脉事件的概率（根据多因素风险函数计算）（41%/33%）。高甘油三酯血症患者初始总体冠状动脉风险较高，从治疗中获益更多。苯扎贝特的耐受性明显优于洛伐他汀（P < 0.001）；大多数不良事件为胃肠道事件（6例对14例，无统计学差异）或肌酸磷酸激酶升高所致（3例对12例，P < 0.05）。
两种治疗均显著降低了患冠心病的风险参数，计算得出的多因素冠状动脉风险也有类似降低。在为中度血脂异常选择药物时，如果止血调节受到干扰，应考虑苯扎贝特对纤维蛋白原水平升高的额外作用。
