Pauciullo P, Borgnino C, Paoletti R, Mariani M, Mancini M
Department of Clinical and Experimental Medicine, Medical School of the University 'Federico II', Via S. Pansini 5, 80131, Naples, Italy.
Atherosclerosis. 2000 Jun;150(2):429-36. doi: 10.1016/s0021-9150(00)00379-8.
Preliminary data suggest that fluvastatin may be safely combined with fibrates. The Fluvastatin Alone and in Combination Treatment Study examined the effects on plasma lipids and safety of a combination of fluvastatin and bezafibrate in patients with coronary artery disease and mixed hyperlipidaemia. A total of 333 patients were randomly allocated in this multicentre double-blind trial to receive 40 mg fluvastatin alone (n=80), 400 mg bezafibrate (n=86), 20 mg fluvastatin+400 mg bezafibrate (n=85) or 40 mg fluvastatin+400 mg bezafibrate (n=82) for 24 weeks. Low-density lipoprotein (LDL)-cholesterol decreased >20% in all fluvastatin-containing regimens, with significantly greater decreases compared with bezafibrate alone (P<0.001). Bezafibrate alone and fluvastatin+bezafibrate combinations resulted in greater increases in high-density lipoprotein (HDL)-cholesterol and decreases in triglycerides compared with fluvastatin alone (P<0.001). Fluvastatin (40 mg)+bezafibrate was the most effective for all lipid parameters with a decrease from baseline at endpoint in LDL-cholesterol of 24%, a decrease in triglycerides of 38% and an increase in HDL-cholesterol of 22%. All treatments were well tolerated with no increase in adverse events for combination therapy versus monotherapy, or between combination regimens. No clinically relevant liver (aspartate aminotransferase [ASAT] or alanine aminotransferase [ALAT]) greater than three times the upper limit of normal) or muscular (creatine phosphokinase (CPK) greater than four times the upper limit of normal) laboratory abnormalities were reported. This large study shows 40 mg fluvastatin in combination with 400 mg bezafibrate to be highly effective and superior to either drug given as monotherapy in mixed hyperlipidaemia, and to be safe and well tolerated.
初步数据表明，氟伐他汀可安全地与贝特类药物联合使用。“氟伐他汀单独及联合治疗研究”考察了氟伐他汀与苯扎贝特联合用药对冠心病合并混合性高脂血症患者血脂的影响及安全性。在这项多中心双盲试验中，共333例患者被随机分配接受以下治疗，为期24周：单独服用40mg氟伐他汀（n = 80）、400mg苯扎贝特（n = 86）、20mg氟伐他汀 + 400mg苯扎贝特（n = 85）或40mg氟伐他汀 + 400mg苯扎贝特（n = 82）。所有含氟伐他汀的治疗方案中，低密度脂蛋白（LDL）胆固醇降低均超过20%，与单独使用苯扎贝特相比，降低幅度显著更大（P < 0.001）。与单独使用氟伐他汀相比，单独使用苯扎贝特以及氟伐他汀 + 苯扎贝特联合用药使高密度脂蛋白（HDL）胆固醇升高幅度更大，甘油三酯降低幅度更大（P < 0.001）。氟伐他汀（40mg）+ 苯扎贝特对所有血脂参数最为有效，至研究终点时，LDL胆固醇较基线降低24%，甘油三酯降低38%，HDL胆固醇升高22%。所有治疗耐受性良好，联合治疗与单药治疗相比，或联合治疗方案之间，不良事件均未增加。未报告有临床意义的肝脏（天冬氨酸转氨酶[ASAT]或丙氨酸转氨酶[ALAT]大于正常上限的三倍）或肌肉（肌酸磷酸激酶[CPK]大于正常上限的四倍）实验室异常。这项大型研究表明，40mg氟伐他汀与400mg苯扎贝特联合使用在混合性高脂血症中非常有效，优于单药治疗，且安全、耐受性良好。
