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Randomized Controlled Trial
. 2013 Oct 5:12:142.
doi: 10.1186/1476-511X-12-142.

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  1 , Kentaro Sakamoto, Takahide Kohro, Raisuke Iijima, Toru Kitazawa, Tsutomu Hirano, Mitsunobu Kawamura, Motoki Tagami, Akira Tanaka, Yasumichi Mori, Tsutomu Yamazaki, Teruo Shiba; RESEARCH Study Group
Affiliations
Randomized Controlled Trial

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 et al. Lipids Health Dis. .

Abstract

Aims: 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.

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: 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.

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Figures

Figure 1
Figure 1
Design scheme for the RESEARCH study. The numbers of patients appear inside brackets. T2DM: type 2 diabetes mellitus.
See this image and copyright information in PMC

References

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