Toho University Ohashi Medical center, Tokyo, Japan.
Lipids Health Dis. 2013 Oct 5;12:142. doi: 10.1186/1476-511X-12-142.
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.
患有高胆固醇血症的同时合并糖尿病的患者，仍需要通过临床干预来管理其存在的心血管疾病高危风险。然而，对于强效他汀类药物未能将胆固醇降低至目标水平的情况，尚未建立第二步策略。在这项研究中，我们旨在证明依折麦布联合强效他汀类药物在降低同时患有 2 型糖尿病和高 LDL-胆固醇血症的日本患者 LDL-C 方面的卓越效果。
招募未能达到目标 LDL-C 值的 T2DM 门诊患者（来自 16 个研究所的 109 名患者），并将其随机分配至两组，即双倍剂量他汀组和依折麦布加他汀组。随访计划安排在 0、12、26 和 52 周。主要终点是从基线到 12 周时 LDL-C 水平的变化百分比。
我们成功地创建了随机分组（性别、年龄、LDL-C、HbA1c 等）的两组，除载脂蛋白-B 和 sd-LDL 略有差异外。
RESEARCH 是第一项比较强效他汀类药物双倍剂量与依折麦布联合强效他汀类药物治疗 2 型糖尿病患者的前瞻性、平行组、多中心研究。RESEARCH 研究将为未能达到目标 LDL-C 值的糖尿病患者提供可靠的证据，从而建立临床策略。
