Pitavastatin and Atorvastatin Double-Blind Randomized ComPArative Study among HiGh-Risk Patients, Including ThOse with Type 2 Diabetes Mellitus, in Taiwan (PAPAGO-T Study)
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BackgroundEvidence 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 ResultsBetween 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 1C 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. ConclusionBoth 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 RegistrationClinicalTrials.gov NCT01386853 http://clinicaltrials.gov/ct2/show/NCT01386853?term=NCT01386853&rank=1
背景：目前已有部分人群的高风险高胆固醇血症患者接受他汀类（statin）药物治疗的疗效与安全性证据，但华裔人群的相关研究数据仍较为有限。为验证匹伐他汀（pitavastatin，2mg/日）在降低低密度脂蛋白胆固醇（low-density lipoprotein cholesterol, LDL-C）方面非劣于阿托伐他汀（atorvastatin，10mg/日）的假说，本研究于中国台湾地区开展了一项为期12周的多中心协作随机平行对照比较研究，纳入高风险华裔高胆固醇血症患者。本研究同时评估了两种药物对其他血脂参数、炎症标志物、胰岛素抵抗相关生物标志物的影响及安全性。方法与结果：2011年7月至2012年4月期间，共筛查251例患者，其中225例[平均年龄：58.7±8.6岁；女性占比38.2%（86/225）]被随机分组，分别接受匹伐他汀（n=112）或阿托伐他汀（n=113）治疗，疗程12周。两组基线特征无显著差异；经12周治疗后，两组低密度脂蛋白胆固醇水平均显著降低：匹伐他汀组降幅为-35.0±14.1%，阿托伐他汀组降幅为-38.4±12.8%（两组均p值具有统计学意义，原文此处存在数据缺失）。此外，阿托伐他汀组的糖化血红蛋白（HbA1c）水平显著升高（p=0.001），而匹伐他汀组未出现该变化。两种他汀类药物均具有良好耐受性，两组治疗期间出现的不良事件发生率均较低且无显著差异。结论：在台湾地区高风险高胆固醇血症华裔患者中，2mg/日匹伐他汀与10mg/日阿托伐他汀均具有良好耐受性，均可降低低密度脂蛋白胆固醇水平，且对血脂谱的改善程度相当。试验注册：ClinicalTrials.gov NCT01386853，详情链接：http://clinicaltrials.gov/ct2/show/NCT01386853?term=NCT01386853&rank=1
