中南大学湘医院余再新教授.pptVIP

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中南大学湘医院余再新教授

* 首先来看Torcetrapib的三项替代终点研究。 ILLUSTRATE、RADIANCE 1和RADIANCE2是分别在冠心病患者、遗传性家族性高胆固醇血症患者(FH)和混合性高脂血症患者中进行的研究,这3项研究为期2年,共入选了超过2,800名患者,采用IVUS或颈动脉B型超声测定,以评估与单用阿托伐他汀相比,Torcetrapib与阿托伐他汀的复方制剂能否更强逆转动脉粥样硬化进程。 研究结果显示, Torcetrapib确实显著升高了HDL-C水平,但令人失望的是,这三项研究均未获得预期结果, Torcetrapib未能显著逆转动脉粥样硬化进程。相反,Torcetrapib还使受试者收缩压升高了4.6mmHg。 RADIANCE 1: A total of 850 patients with heterozygous familial hypercholesterolemia underwent B-mode ultrasonography at baseline and at follow-up to measure changes in carotid intima–media thickness. The patients completed an atorvastatin run-in period and were subsequently randomly assigned to receive either atorvastatin monotherapy or atorvastatin combined with 60 mg of torcetrapib for 2 years. After 24 months, in the atorvastatin-only group, the mean (±SD) HDL cholesterol level was 52.4±13.5 mg per deciliter and the mean low-density lipoprotein (LDL) cholesterol level was 143.2±42.2 mg per deciliter, as compared with 81.5±22.6 mg per deciliter and 115.1±48.5 mg per deciliter, respectively, in the torcetrapib–atorvastatin group. During the study, average systolic blood pressure increased by 2.8 mm Hg in the torcetrapib–atorvastatin group, as compared with the atorvastatinonly group. The increase in maximum carotid intima–media thickness, the primary measure of efficacy, was 0.0053±0.0028 mm per year in the atorvastatin-only group and 0.0047±0.0028 mm per year in the torcetrapib–atorvastatin group H(P = 0.87). RADIANCE 2: We did a randomised double-blind trial at 64 centres in North America and Europe. 752 eligible participants completed an atorvastatin-only run-in period for dose titration, after which they all continued to receive atorvastatin at the titrated dose. 377 of these patients were randomly assigned to receive 60 mg of torcetrapib per day and 375 to placebo. We made carotid ultrasound images at baseline and at 6-month intervals for 24 months. The primary endpoint was the yearly rate of change in the maximum intima-media thickness of 12 caro

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