台湾高风险患者（包括 2 型糖尿病患者）中匹伐他汀与阿托伐他汀的双盲随机对照研究（PAPAGO-T 研究）。
Pitavastatin and Atorvastatin double-blind randomized comPArative study among hiGh-risk patients, including thOse with Type 2 diabetes mellitus, in Taiwan (PAPAGO-T Study).
机构信息
Division of Cardiology, Internal Medicine, National Cheng Kung University Hospital, Tainan, Taiwan ; Institute of Clinical Medicine, National Cheng Kung University, Tainan, Taiwan.
出版信息
PLoS One. 2013 Oct 1;8(10):e76298. doi: 10.1371/journal.pone.0076298. eCollection 2013.
BACKGROUND
Evidence about the efficacy and safety of statin treatment in high-risk patients with hypercholesterolemia is available for some populations, but not for ethnic Chinese. To test the hypothesis that treatment with pitavastatin (2 mg/day) is not inferior to treatment with atorvastatin (10 mg/day) for reducing low-density lipoprotein cholesterol (LDL-C), a 12-week multicenter collaborative randomized parallel-group comparative study of high-risk ethnic Chinese patients with hypercholesterolemia was conducted in Taiwan. In addition, the effects on other lipid parameters, inflammatory markers, insulin-resistance-associated biomarkers and safety were evaluated.
METHODS AND RESULTS
Between July 2011 and April 2012, 251 patients were screened, 225 (mean age: 58.7 ± 8.6; women 38.2% [86/225]) were randomized and treated with pitavastatin (n = 112) or atorvastatin (n = 113) for 12 weeks. Baseline characteristics in both groups were similar, but after 12 weeks of treatment, LDL-C levels were significantly lower: pitavastatin group = -35.0 ± 14.1% and atorvastatin group = -38.4 ± 12.8% (both: p < 0.001). For the subgroup with diabetes mellitus (DM) (n = 125), LDL-C levels (-37.1 ± 12.9% vs. -38.0 ± 13.1%, p = 0.62) were similarly lowered after either pitavastatin (n = 63) or atorvastatin (n = 62) treatment. Triglycerides, non-high density lipoprotein cholesterol, and apoprotein B were similarly and significantly lower in both treatment groups. In non-lipid profiles, HOMA-IR and insulin levels were higher to a similar degree in both statin groups. Hemoglobin A1C was significantly (p = 0.001) higher in the atorvastatin group but not in the pitavastatin group. Both statins were well tolerated, and both groups had a similar low incidence of treatment-emergent adverse events.
CONCLUSION
Both pitavastatin (2 mg/day) and atorvastatin (10 mg/day) were well tolerated, lowered LDL-C, and improved the lipid profile to a comparable degree in high-risk Taiwanese patients with hypercholesterolemia.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01386853 http://clinicaltrials.gov/ct2/show/NCT01386853?term=NCT01386853&rank=1.
背景
已有一些人群的高胆固醇血症高危患者应用他汀类药物治疗的疗效和安全性证据，但尚无华裔人群的相关证据。为验证匹伐他汀（2 mg/日）治疗降低低密度脂蛋白胆固醇（LDL-C）的疗效不劣于阿托伐他汀（10 mg/日）的假设，我们在台湾开展了一项为期 12 周、多中心、协作、随机、平行分组比较性研究，纳入了高胆固醇血症高危的华裔患者。此外，还评估了其他血脂参数、炎症标志物、与胰岛素抵抗相关的生物标志物以及安全性。
方法和结果
2011 年 7 月至 2012 年 4 月期间，共筛查了 251 例患者，其中 225 例（平均年龄：58.7±8.6 岁；女性占 38.2%[86/225]）被随机分至匹伐他汀组（n=112）或阿托伐他汀组（n=113），接受为期 12 周的治疗。两组患者的基线特征相似，但治疗 12 周后，LDL-C 水平显著降低：匹伐他汀组为-35.0±14.1%，阿托伐他汀组为-38.4±12.8%（均<0.001）。对于糖尿病（DM）亚组（n=125），LDL-C 水平在匹伐他汀（n=63）或阿托伐他汀（n=62）治疗后也均显著降低（-37.1±12.9% vs. -38.0±13.1%，p=0.62）。两组的甘油三酯、非高密度脂蛋白胆固醇和载脂蛋白 B 均同样且显著降低。在非脂类指标中，匹伐他汀组和阿托伐他汀组的 HOMA-IR 和胰岛素水平均升高，程度相似。血红蛋白 A1C 在阿托伐他汀组显著升高（p=0.001），而在匹伐他汀组无此变化。两种他汀类药物均耐受良好，两组的治疗中出现的不良事件发生率相似。
结论
在台湾高胆固醇血症高危患者中，匹伐他汀（2 mg/日）和阿托伐他汀（10 mg/日）均耐受良好，均能降低 LDL-C，改善血脂谱，疗效相当。
临床试验注册
ClinicalTrials.gov NCT01386853 http://clinicaltrials.gov/ct2/show/NCT01386853?term=NCT01386853&rank=1.
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