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

Takeshi Inazawa,Tsutomu Yamazaki,Mitsunobu Kawamura,Tsutomu Hirano,Toru Kitazawa,Kentaro Sakamoto,Takahide Kohro,Akira Tanaka,Motoki Tagami,Yasumichi Mori,Teruo Shiba,Raisuke Iijima

doi:10.1186/1476-511x-12-142

Abstract

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.

Highlights

The incidence of metabolic disease, a condition often associated with coronary artery disease (CAD) or stroke is increasing substantially all over the world
The RESEARCH study will provide reliable evidence with which to establish a clinical strategy for diabetics who fail to achieve the target low-density lipoprotein cholesterol (LDL-C) value
In this study we seek to demonstrate the superior effect of ezetimibe-plus-strong-statin in reducing LDL-C levels in Japanese patients suffering from both type 2 diabetes mellitus (T2DM) and hyper LDL cholesterolemia

Summary

Methods

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. Interim results: We could successfully create randomized (gender, age, LDL-C, HbA1c, etc.) two groups except for slight differences in apolipoprotein-B and sd-LDL

Conclusions

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Findings

Discussion