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
1 Kashiwa City Hospital, Chiba, Japan
2 Toho University Ohashi Medical center, Tokyo, Japan
3 Jichi Medical University, Tochigi, Japan
4 Japanese Red Cross Medical Center, Tokyo, Japan
5 Showa University School of Medicine, Tokyo, Japan
6 Tokyo Teishin Hospital, Tokyo, Japan
7 Sanraku Hospital, Life-style related Disease Clinic, Tokyo, Japan
8 Kagawa Nutrition University, Nutrition Clinic, Tokyo, Japan
9 Toranomon Hospital, Tokyo, Japan
10 The University of Tokyo Hospital, Tokyo, Japan
11 Mitsui Memorial Hospital, Tokyo, Japan
Lipids in Health and Disease 2013, 12:142 doi:10.1186/1476-511X-12-142Published: 5 October 2013
Hypercholesterolemia 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.
T2DM 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.
We could successfully create randomized (gender, age, LDL-C, HbA1c, etc.) two groups except for slight differences in apolipoprotein-B and sd-LDL.
RESEARCH 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.