학술논문
匹伐他汀治疗高胆固醇血症安全性和有效性的多中心观察 / Safety and efficacy of pitavastatin in patients with hypercholesterolemia: a multicenter study
Document Type
Academic Journal
Author
毛勇; 余金明; 战义强; 胡大一; 丁荣晶; 张芬; 李社昌; 孔群钰; 林凡礼; 贾贡献; MAO Yong; YU Jin-ming; ZHAN Yi-qiang; HU Da-yi; DING Rong-jing; ZHANG Fen; LI She-chang; KONG Qun-yu; LIN Fan-li; JIA Gong-xian
Source
中华医学杂志 / National Medical Journal of China. 92(14):968-973
Subject
Language
Chinese
ISSN
0376-2491
Abstract
目的 考察广泛使用条件下匹伐他汀用于中国高胆固醇血症患者调脂的安全性和有效性.方法 以多中心、非盲、不设平等对照的方式开展为期12周的Ⅳ期临床试验.结果 安全集427例受试者的不良事件主要有呕吐、肌痛以及天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、肌酸激酶(CK)升高等,与试验药物相关的不良事件发生率为4.22％.受试对象用药前后肾功能和血常规指标的差异均无统计学意义(均P＞0.05),未出现AST、ALT值超过3倍医学参考值上限(3×ULN)或CK值超过10×ULN的受试者.符合方案集397例受试者治疗12周时,无入组前调脂治疗组的总胆固醇和低密度脂蛋白胆固醇(LDL-C)水平分别下降24.6％和31.0％,基线高密度脂蛋白胆固醇(HDL-C)＜1.04 mmol/L组的HDL-C水平上升60.1％,基线甘油三酯(TG)＞1.70 mmol/L组的TG水平下降22.5％ (P＜0.05)；207例(92.3％)低危患者、46例(76.1％)中危患者、134例(47.8％)高危患者和10例(40.0％)极高危患者的LDL-C值达到治疗目标值；由其他调脂药物转换为匹伐他汀的受试者的LDL-C达标率显著高于转换前(P＜0.05).结论 匹伐他汀具有良好的安全性和有效性,可用于我国高胆固醇血症患者的治疗.
Objective To evaluate the safety and efficacy of pitavastatin in patients with hypercholesterolemia in China under conditions of extensive usage.Methods This was a 12-week,multicenter,open-label,without parallcl-group comparison,phase Ⅳ clinical trial.Results There were 427 subjects in the safety set.The adverse events mainly included vomiting,myalgia and the elevations of aspartate transaminasc (AST),alanine transaminase (ALT) and creatine kinase (CK),etc.The incidence of drug-related adverse events was 4.22％.There were no significant differences between pre-exposure and post-exposure average levels of renal function indicators and blood routine examination item (all P＞0.05).None of them had a high AST/ALT value,i.e.＞3 times upper limits of normal (ULN),or had a high CK value,i.e.＞10 times ULN.There were 397 subjects in the per protocol set.At week 12 post-treatment,the blood levels of total cholesterol and low density lipoprotein cholcsterol(LDL-C) in subjects without previous treatment decreased 24.6％ and 31.0％ respectively,that of high density lipoprotein cholesterol (HDL-C) in subjects with HDL-C ＜1.04 mmol/L increased 60.1％ while that of triglyceride (TG) in subjects with TG ＞1.70 mmol/L decreased 22.5％ (P＜0.05).And 207 (92.3％) subjects were at a low risk,46(76.1％) subjects at an intermediate risk,134(47.8％) subjects at a high risk and 10(40.0％) of subjects at a very high risk had achieved a LDL-C target value; the LDL-C goal achievement rate after switching from previous medication to pitavastatin was significant higher than that of pre-switching.Conclusion Pitavastatin demonstrates positive safety and efficacy.It may be used for the treatment of patients with hypercholesterolemia in China.
Objective To evaluate the safety and efficacy of pitavastatin in patients with hypercholesterolemia in China under conditions of extensive usage.Methods This was a 12-week,multicenter,open-label,without parallcl-group comparison,phase Ⅳ clinical trial.Results There were 427 subjects in the safety set.The adverse events mainly included vomiting,myalgia and the elevations of aspartate transaminasc (AST),alanine transaminase (ALT) and creatine kinase (CK),etc.The incidence of drug-related adverse events was 4.22％.There were no significant differences between pre-exposure and post-exposure average levels of renal function indicators and blood routine examination item (all P＞0.05).None of them had a high AST/ALT value,i.e.＞3 times upper limits of normal (ULN),or had a high CK value,i.e.＞10 times ULN.There were 397 subjects in the per protocol set.At week 12 post-treatment,the blood levels of total cholesterol and low density lipoprotein cholcsterol(LDL-C) in subjects without previous treatment decreased 24.6％ and 31.0％ respectively,that of high density lipoprotein cholesterol (HDL-C) in subjects with HDL-C ＜1.04 mmol/L increased 60.1％ while that of triglyceride (TG) in subjects with TG ＞1.70 mmol/L decreased 22.5％ (P＜0.05).And 207 (92.3％) subjects were at a low risk,46(76.1％) subjects at an intermediate risk,134(47.8％) subjects at a high risk and 10(40.0％) of subjects at a very high risk had achieved a LDL-C target value; the LDL-C goal achievement rate after switching from previous medication to pitavastatin was significant higher than that of pre-switching.Conclusion Pitavastatin demonstrates positive safety and efficacy.It may be used for the treatment of patients with hypercholesterolemia in China.