当前位置: X-MOL 学术Diabetes Care › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Efficacy and Safety of Diacerein in Patients With Inadequately Controlled Type 2 Diabetes: A Randomized Controlled Trial
Diabetes Care ( IF 14.8 ) Pub Date : 2017-08-17 , DOI: 10.2337/dc17-0374
Claudia R L Cardoso 1 , Nathalie C Leite 1 , Fernanda O Carlos 1 , Andréia A Loureiro 1 , Bianca B Viegas 1 , Gil F Salles 2
Affiliation  

OBJECTIVE To assess, in a randomized, double-blind, and placebo-controlled trial, the efficacy and safety of diacerein, an immune modulator anti-inflammatory drug, in improving glycemic control of patients with type 2 diabetes.

RESEARCH DESIGN AND METHODS Eighty-four patients with HbA1c between 7.5 and 9.5% (58–80 mmol/mol) were randomized to 48-week treatment with placebo (n = 41) or diacerein 100 mg/day (n = 43). The primary outcome was the difference in mean HbA1c changes during treatment. Secondary outcomes were other efficacy and safety measurements. A general linear regression with repeated measures, adjusted for age, sex, diabetes duration, and each baseline value, was used to estimate differences in mean changes. Both intention-to-treat (ITT) analysis and per-protocol analysis (excluding 10 patients who interrupted treatment) were performed.

RESULTS Diacerein reduced HbA1c compared with placebo by 0.35% (3.8 mmol/mol; P = 0.038) in the ITT analysis and by 0.41% (4.5 mmol/mol; P = 0.023) in the per-protocol analysis. The peak of effect occurred at the 24th week of treatment (−0.61% [6.7 mmol/mol; P = 0.014] and −0.78% [8.5 mmol/mol; P = 0.005], respectively), but it attenuated toward nonsignificant differences at the 48th week. No significant effect of diacerein was observed in other efficacy and safety measures. Diarrhea occurred in 65% of patients receiving diacerein and caused treatment interruption in 16%. Seven patients in the diacerein group reduced insulin dosage, whereas 10 in the placebo group increased it; however, mild hypoglycemic events were equally observed.

CONCLUSIONS Diacerein reduced mean HbA1c levels, with peak of effect at the 24th week of treatment. The drug was well tolerated and may be indicated as adjunct treatment in patients with type 2 diabetes, particularly in those with osteoarthritis.



中文翻译:

双醋瑞因在控制不充分的 2 型糖尿病患者中的疗效和安全性:一项随机对照试验

目的在一项随机、双盲和安慰剂对照试验中评估双醋瑞因(一种免疫调节剂抗炎药)在改善 2 型糖尿病患者血糖控制方面的有效性和安全性。

研究_ _ _ _ _ _ 主要结果是治疗期间平均 HbA 1c变化的差异。次要结果是其他疗效和安全性测量。使用重复测量的一般线性回归,调整年龄、性别、糖尿病病程和每个基线值,用于估计平均变化的差异。进行了意向治疗 (ITT) 分析和符合方案分析(不包括 10 名中断治疗的患者)。

结果在 ITT 分析中,与安慰剂相比,双醋瑞因降低了 HbA 1c 0.35%(3.8 mmol/mol; P = 0.038),在符合方案分析中降低了 0.41%(4.5 mmol/mol; P = 0.023)。效果峰值出现在治疗的第 24 周(-0.61% [6.7 mmol/mol;P = 0.014] 和 -0.78% [8.5 mmol/mol;P= 0.005]),但它在第 48 周时向不显着的差异减弱。在其他疗效和安全措施中未观察到双醋瑞因的显着影响。65% 接受双醋瑞因的患者出现腹泻,16% 的患者出现治疗中断。双醋瑞因组 7 名患者减少了胰岛素剂量,而安慰剂组 10 名患者增加了胰岛素剂量;然而,同样观察到轻度低血糖事件。

结论双醋瑞因降低了平均 HbA 1c水平,在治疗的第 24 周达到峰值。该药物耐受性良好,可作为 2 型糖尿病患者的辅助治疗,尤其是骨关节炎患者。

更新日期:2017-09-08
down
wechat
bug