Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, P.O. Box: 13145-784, Tehran, Iran.
Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.
J Endocrinol Invest. 2019 Jul;42(7):851-857. doi: 10.1007/s40618-018-0991-0. Epub 2018 Dec 10.
To compare the efficacy of sitagliptin versus pioglitazone as add-on drugs in patients with poorly controlled diabetes with metformin and sulfonylureas.
This is a randomized, open-label, parallel assignment clinical trial. Patients who had inadequate glycemic control [7% (53 mmol/mol) ≤ A1C < 11% (97 mmol/mol)] despite a minimum 6-month period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day were enrolled in the study. HbA1C, fasting blood glucose (FBG), fasting plasma lipid parameters [total cholesterol (TC0, low-density lipoprotein cholesterol (LDL-C), triglycerides (TG) and high-density lipoprotein cholesterol (HDL-C)], systolic and diastolic blood pressure (SBP, DBP), weight, waist circumference, and body mass index were measured at baseline and after 17, 34, and 52 weeks of treatment. Generalized estimating equation analysis was done to compare treatment groups for continuous efficacy parameters.
No significant difference in HbA1C reduction was observed between the treatment groups during the study course. (P = 0.149, adjusted P = 0.434; coefficient - 0.11 ± 0.08). The FBG (P = 0.032; coefficient 7.44 ± 3.48), HDL-C (P = 0.001; coefficient - 2.69 ± 0.83), TG (P = 0.027; coefficient 12.63 ± 5.71) and SBP (P < 0.001; coefficient 5.43 ± 1.26) changes from baseline, and weight gain were greater in the pioglitazone group. The mean changes in LDL-C and TC from baseline to week 52 were greater in the sitagliptin group (P = 0.034; coefficient - 7.40 ± 3.50, P = 0.013; coefficient - 7.16 ± 2.88, respectively).
Sitagliptin and pioglitazone were equally effective in improvement of HbA1C. There were some differences in terms of lipid indices, weight gain, and SBP. The current study confirmed that both sitagliptin and pioglitazone are effective treatment options and the decision should be made for each individual based on the baseline characteristics.
比较西格列汀与吡格列酮作为二甲双胍和磺酰脲类药物控制不佳的糖尿病患者的附加药物的疗效。
这是一项随机、开放标签、平行分组的临床试验。纳入研究的患者在接受二甲双胍 2000mg/天和格列齐特 240mg/天治疗至少 6 个月后，血糖仍控制不佳[7%（53mmol/mol）≤A1C＜11%（97mmol/mol）]。在基线和治疗 17、34 和 52 周时测量糖化血红蛋白（HbA1C）、空腹血糖（FBG）、空腹血脂参数[总胆固醇（TC0）、低密度脂蛋白胆固醇（LDL-C）、甘油三酯（TG）和高密度脂蛋白胆固醇（HDL-C）]、收缩压和舒张压（SBP、DBP）、体重、腰围和体重指数。使用广义估计方程分析比较治疗组的连续疗效参数。
在研究过程中，两组之间 HbA1C 降低无显著差异。（P=0.149，调整后 P=0.434；系数-0.11±0.08）。FBG（P=0.032；系数 7.44±3.48）、HDL-C（P=0.001；系数-2.69±0.83）、TG（P=0.027；系数 12.63±5.71）和 SBP（P＜0.001；系数 5.43±1.26）从基线的变化以及吡格列酮组体重增加更大。与基线相比，西格列汀组 LDL-C 和 TC 从第 52 周的平均变化更大（P=0.034；系数-7.40±3.50，P=0.013；系数-7.16±2.88）。
西格列汀和吡格列酮在改善 HbA1C 方面同样有效。在血脂指数、体重增加和 SBP 方面存在一些差异。本研究证实，西格列汀和吡格列酮均为有效治疗选择，应根据个体基线特征做出决策。
