RESEARCH (Recognized effect of Statin and ezetimibe therapy for achieving LDL-C Goal), a randomized, doctor-oriented, multicenter trial to compare the effects of higher-dose statin versus ezetimibe-plus-statin on the serum LDL-C concentration of Japanese type-2 diabetes patients design and rationale

Lipids in Health and Disease

Research

Toru Kitazawa¹  Takahide Kohro²  Akira Tanaka³  Takeshi Inazawa⁴  Motoki Tagami⁵  Tsutomu Hirano⁶  Tsutomu Yamazaki⁷  Raisuke Iijima⁸  Kentaro Sakamoto⁸  Teruo Shiba⁹  Mitsunobu Kawamura^1,10  Yasumichi Mori^1,11 

[1] Japanese Red Cross Medical Center, Tokyo, Japan;Jichi Medical University, Tochigi, Japan;Kagawa Nutrition University, Nutrition Clinic, Tokyo, Japan;Kashiwa City Hospital, Chiba, Japan;Sanraku Hospital, Life-style related Disease Clinic, Tokyo, Japan;Showa University School of Medicine, Tokyo, Japan;The University of Tokyo Hospital, Tokyo, Japan;Toho University Ohashi Medical center, Tokyo, Japan;Toho University Ohashi Medical center, Tokyo, Japan;Mitsui Memorial Hospital, Tokyo, Japan;Tokyo Teishin Hospital, Tokyo, Japan;Toranomon Hospital, Tokyo, Japan;

关键词: Hypercholesterolemia;    Ezetimibe;    Statin;   

DOI  :  10.1186/1476-511X-12-142

 received in 2013-07-17, accepted in 2013-09-26,  发布年份 2013

来源: Springer

【 摘 要 】

AimsHypercholesterolemia coexisting with diabetes still requires clinical intervention to manage the high risk of cardiovascular disease it poses. No second-step strategy is established, however, for cases where strong statins fail to bring cholesterol down to target levels. In this study we seek to demonstrate the superior effect of ezetimibe in combination with strong statins to reduce LDL-C in Japanese patients suffering from both T2DM and hyper LDL-cholesterolemia.MethodsT2DM outpatients (109 patients from 16 institutes) who failed to achieve the target LDL-C value were recruited and randomly assigned to two groups, a double-dose-statin group and ezetimibe-plus-statin group. Follow-ups were scheduled at 0, 12, 26, and 52 weeks. The primary endpoint was the percentage change in the level of LDL-C from baseline to 12 weeks.Interim resultsWe could successfully create randomized (gender, age, LDL-C, HbA1c, etc.) two groups except for slight differences in apolipoprotein-B and sd-LDL.ConclusionsRESEARCH is the first prospective, parallel-group, multicenter study comparing a double dose of strong statin with ezetimibe plus strong statin for T2DM patients. The RESEARCH study will provide reliable evidence with which to establish a clinical strategy for diabetics who fail to achieve the target LDL-C value.

【 授权许可】

Unknown   
© Inazawa et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.