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SAFARI TRIAL - Superior efficacy of combination therapy over monotherapy ? SAFARI1 was a multicenter, randomized, double-blind study conducted in the US to assess the 18-week efficacy, safety and tolerability of simvastatin (20 mg/day) plus 非诺贝特e (160 mg/day) combination therapy compared with simvastatin alone (20 mg/day) in patients with combined hyperlipidemia (fasting triglyceride [TG] levels 150-500 mg/dl, and LDL-cholesterol [LDL-C] 130 mg/dl). ? This slide shows the percentage change in median lipid levels between baseline and week 18 for both treatment groups (combination therapy and simvastatin alone). Both treatments were associated with desirable changes in all lipid parameters shown (LDL-cholesterol, TG and HDL-cholesterol), and also in VLDL-cholesterol and in non-HDL-cholesterol (not shown). ? In each case, combination therapy was significantly more effective than monotherapy in achieving the desired change in levels (p 0.001). No drug-related serious adverse events were observed. ? SAFARI1是一项在US进行的多中心、随机、双盲研究,为期18周,用于比较辛伐他汀(20mg/天)联合非诺贝特(160mg/天)和单独使用辛伐他汀(20mg/天)的疗效和安全性。患者为混合性高血脂患者(空腹甘油三酯水平[TG]150-500 mg/dl, LDL-C 130 mg/dl)。 ? 这张幻灯片显示的是联合治疗和辛伐他汀单独治疗组的酯水平中位数在基线期和18周的百分比改变。两组治疗的酯参数的改变都很好(LDL-C, TG 和 HDL-C),以及VLDL-C和非HDL-C(本片未显示)。 ? 在每一个病例中,在达到预期的改变水平上联合治疗较单药治疗更加有效。(p 0.001)。 ? 无药物相关严重不良反应发生。 Reference : 1. Grundy et al. Am J Cardiol 2005;95:462-8 氟伐他汀单独或联合治疗研究(fluvastatin alone or combination treatment,FACT)为多中心、随机双盲的前瞻性研究,冠心病和混合型血脂紊乱患者入选。 氟伐他汀与苯扎贝特合用有效降低LDL-C达24% ,甘油三酯38%和升高HDL-C 22%,优于单药治疗时的降脂疗效 In patients with diabetes, combination therapy with a statin and a fibrate is often necessary to provide sufficient increases in HDL-C levels and decreases in triglyceride levels, but statin metabolism can be modified by fibrates, causing significant elevations in CK levels and therefore increasing the risk of rhabdomyolysis. Indeed, cases of rhabdomyolysis have been recorded for all statins in combination with fibrates (Omar and Wilson,
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