Department of Internal Medicine, Teikyo University School of Medicine, Tokyo, Japan.
Expert Opin Pharmacother. 2010 Apr;11(5):817-28. doi: 10.1517/14656561003641990.
Many clinical trials of pitavastatin have been done since its launch. New insights on pitavastatin from these trials are summarized and evaluated.
The results of clinical studies using pitavastatin, from 2008 to 2009, the LIVES study, the JAPAN-ACS study, the CHIBA study, the PIAT study and Phase III clinical trials in the West are reviewed.
In the LIVES study, pitavastatin showed significant and continuous elevation of high-density lipoprotein cholesterol (HDL-C), estimated glomerular filtration rate (eGFR), as well as potential decrease in low-density lipoprotein cholesterol (LDL-C), in addition to long-term safety. Non-inferiority of pitavastatin against atorvastatin in the percentage change in plaque volume was proved in the JAPAN-ACS study. Also, comparable effects on LDL-C reduction rate of pitavastatin versus atorvastatin were confirmed in the CHIBA study and Phase III clinical trials in the West, and a greater increase in HDL-C was observed than with atorvastatin in the PIAT study.
Pitavastatin is a useful potent stain in raising HDL-C as well as in lowering of LDL-C, though a large-scale, clinical trial to confirm prevention of cardiovascular events is needed in the future.
自匹伐他汀推出以来，已经进行了许多临床试验。从这些试验中总结和评估了匹伐他汀的新见解。
回顾了 2008 年至 2009 年期间使用匹伐他汀的临床研究结果，包括 LIVES 研究、JAPAN-ACS 研究、CHIBA 研究、PIAT 研究以及西方的 III 期临床试验。
在 LIVES 研究中，匹伐他汀显示出显著且持续的高密度脂蛋白胆固醇（HDL-C）升高、肾小球滤过率（eGFR）升高，以及 LDL-C 潜在降低，此外还具有长期安全性。在 JAPAN-ACS 研究中，证明了匹伐他汀与阿托伐他汀在斑块体积百分比变化方面的非劣效性。此外，在 CHIBA 研究和西方的 III 期临床试验中，也证实了匹伐他汀与阿托伐他汀降低 LDL-C 率的效果相当，并且与阿托伐他汀相比，HDL-C 升高幅度更大。
匹伐他汀是一种有效的他汀类药物，既能升高 HDL-C，又能降低 LDL-C，但未来仍需要进行大规模的临床试验来证实其对心血管事件的预防作用。
