与辛伐他汀（舒降之）相比，辛伐他汀仿制药在泰国高胆固醇血症患者中的降低密度脂蛋白胆固醇效果——一项随机交叉研究，泰国的首份报告

LDL-cholesterol lowering effect of a generic product of simvastatin compared to simvastatin (Zocor) in Thai hypercholesterolemic subjects -- a randomized crossover study, the first report from Thailand.

作者信息

Wiwanitkit Viroj, Wangsaturaka Danai, Tangphao Oranee

机构信息

Department of Laboratory Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand.

出版信息

BMC Clin Pharmacol. 2002;2:1. doi: 10.1186/1472-6904-2-1. Epub 2002 Jan 30.

DOI:10.1186/1472-6904-2-1

PMID:11835697

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC65514/

Abstract

BACKGROUND

It is commonly agreed that people with a high blood LDL-cholesterol will have a higher risk of coronary artery disease (CAD) than people with low blood LDL-cholesterol. Due to the increasingly high costs of medication in Thailand, the government has set up several measures to combat the problem. One of such strategies is to promote the utilization of locally manufactured drug products, especially those contained in the National Drug List. Simvastatin, an HMG-CoA reductase inhibitor, is listed as an essential drug for the treatment of hypercholesterolemia. Here, we reported the study on the LDL-cholesterol-lowering effect of a generic simvastatin product in comparison with the Zocor, in 43 healthy thai volunteers.

METHOD

The generic product tested was Eucor, locally manufactured by Greater Pharma Ltd., Part, Thailand, and the reference product was Zocor (Merck Sharp & Dohme, USA). The two products were administered as 10-mg single oral doses in a two-period crossover design. After drug administration, serial blood samples were collected every 4 weeks for 16 weeks. The major parameter monitored in this study was blood LDL-cholesterol.

RESULT

After taking the drugs for the first 8 weeks, no statistically significant difference was detected in blood LDL-cholesterol between the first (Zocor-treated) and the second (Eucor-treated) groups. After crossover and taking drugs for further 8 weeks, a similar result was obtained, i.e., no significant difference in blood LDL-cholesterol between the first (Eucor-treated) and the second (Zocor-treated) groups was observed. Upon completion of the 16-week study, there was also no statistically significant difference in the changes of all tested blood parameters between the two products (randomized block ANOVA, N = 37). Only minor side effects, mainly dizziness and nausea, were observed in both products.

CONCLUSION

Our study demonstrated no significant differences in the therapeutic effect and safety between the generic and original simvastatin products.

摘要

背景

人们普遍认为，血液中低密度脂蛋白胆固醇（LDL-胆固醇）水平高的人患冠状动脉疾病（CAD）的风险高于血液中LDL-胆固醇水平低的人。由于泰国药品成本日益高昂，政府已采取多项措施应对这一问题。其中一项策略是推广使用本地生产的药品，特别是列入国家药品清单的药品。辛伐他汀是一种HMG-CoA还原酶抑制剂，被列为治疗高胆固醇血症的基本药物。在此，我们报告了一项针对43名健康泰国志愿者的研究，比较了一种仿制药辛伐他汀与舒降之（Zocor）降低LDL-胆固醇的效果。

方法

所测试的仿制药是由泰国大药厂有限公司生产的尤可（Eucor），参比产品是舒降之（美国默克雪兰诺公司）。两种产品均采用10毫克单次口服剂量，采用两期交叉设计给药。给药后，每4周采集一次系列血样，共采集16周。本研究监测的主要参数是血液中的LDL-胆固醇。

结果

服药前8周后，第一组（舒降之治疗组）和第二组（尤可治疗组）的血液LDL-胆固醇水平未检测到统计学上的显著差异。交叉给药并继续服药8周后，得到了类似的结果，即第一组（尤可治疗组）和第二组（舒降之治疗组）的血液LDL-胆固醇水平也未观察到显著差异。在为期16周的研究结束时，两种产品之间所有测试血液参数的变化也没有统计学上的显著差异（随机区组方差分析，N = 37）。两种产品均仅观察到轻微的副作用，主要是头晕和恶心。