Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong, China.
Diabetes Obes Metab. 2011 Sep;13(9):806-13. doi: 10.1111/j.1463-1326.2011.01411.x.
To examine the efficacy, safety and tolerability of rivoglitazone, a novel thiazolidinedione (TZD), and explore its effects on glucose and lipid control compared to placebo and pioglitazone in Chinese type 2 diabetic patients who are treatment naÏve or treated with a single oral blood glucose-lowering drug.
This was a double-blind, randomized, placebo- and active-controlled study. A total of 287 Chinese type 2 diabetic patients with suboptimal glycaemic control (defined as HbA1c ≥6.5 to <10% and fasting plasma glucose ≥7 to ≤15 mmol/l) were enrolled. One hundred and seventy-four eligible patients were randomized into one of the five treatment arms for 12 weeks: placebo, pioglitazone 30 mg daily, rivoglitazone of dose 0.5, 1.0 or 1.5 mg daily. In a full set analysis, we used analysis of covariance to compare the primary endpoint defined as change in HbA1c from baseline to week 12/last observation carried forward in the rivoglitazone group at each dose level with the placebo group.
Changes in HbA1c were -0.11% in the 0.5-mg group; -0.22% in the 1-mg group and -0.17% in the 1.5-mg rivoglitazone group; -0.06% in the 30-mg pioglitazone group and 0.61% in the placebo group. Compared to placebo, changes were significant in all active treatment groups (all p < 0.05). Increase in high-density lipoprotein cholesterol and decrease in triglyceride were observed in the rivoglitazone 1 and 1.5 mg groups, respectively, compared to placebo from baseline to week 12 (p < 0.05). Drug-related oedema was reported in eight patients (7.7%) in all rivoglitazone groups compared to six patients (16.2%) in the pioglitazone group and one patient (3.0%) in the placebo group.
Rivoglitazone is an efficacious, safe and well-tolerated TZD which improved glycaemic control in Chinese type 2 diabetic patients up to 3 months.
评估新型噻唑烷二酮类药物罗格列酮（rivoglitazone）在中国 2 型糖尿病患者中的疗效、安全性和耐受性，探索其在血糖和血脂控制方面与安慰剂和吡格列酮相比的效果，这些患者要么未经治疗，要么仅使用一种口服降糖药物治疗。
这是一项双盲、随机、安慰剂和活性对照研究。共纳入 287 例血糖控制不佳（定义为 HbA1c≥6.5%但＜10%，空腹血浆葡萄糖≥7 但≤15mmol/l）的中国 2 型糖尿病患者。174 例合格患者被随机分为 5 个治疗组中的 1 个，接受为期 12 周的治疗：安慰剂、吡格列酮 30mg 每日 1 次、罗格列酮 0.5、1.0 或 1.5mg 每日 1 次。在全分析集（full set analysis）中，我们采用协方差分析比较了各剂量水平的罗格列酮组与安慰剂组的主要终点（定义为从基线到第 12 周/最后观察到的向前结转的 HbA1c 变化）。
0.5mg 组的 HbA1c 变化为-0.11%；1mg 组为-0.22%；1.5mg 组为-0.17%；30mg 吡格列酮组为-0.06%；安慰剂组为 0.61%。与安慰剂相比，所有活性治疗组的变化均有统计学意义（均 p＜0.05）。与安慰剂相比，罗格列酮 1mg 和 1.5mg 组从基线到第 12 周高密度脂蛋白胆固醇升高，三酰甘油降低（均 p＜0.05）。与吡格列酮组的 6 例（16.2%）和安慰剂组的 1 例（3.0%）相比，所有罗格列酮组均有 8 例（7.7%）患者报告与药物相关的水肿。
罗格列酮是一种有效、安全且耐受良好的噻唑烷二酮类药物，可改善中国 2 型糖尿病患者 3 个月的血糖控制。
