Derosa Giuseppe, Mugellini Amedeo, Ciccarelli Leonardina, Crescenzi Giuseppe, Fogari Roberto
Department of Internal Medicine and Therapeutics, University of Pavia, IRCCS Policlinico S Matteo, P le C Golgi 2, 27100 Pavia, Italy.
Diabetes Res Clin Pract. 2003 Jun;60(3):161-9. doi: 10.1016/s0168-8227(03)00057-3.
To compare glycaemic control and cardiovascular risk profile in patients with type 2 diabetes following 12 months' treatment with either repaglinide or metformin.
This was an open uncontrolled randomised study in n=112 patients with inadequately controlled type 2 diabetes not previously treated with oral hypoglycaemic agents. Patients beginning treatment with either repaglinide or metformin entered an 8-week titration period (to optimise dosage: repaglinide, 2-4 mg/day; metformin, 1500-2500 mg/day) followed by a 12-month treatment period. Glycaemic control and cardiovascular risk factors were determined at baseline and at the end of the treatment period.
Mean (S.D.) final drug doses were 3 (+/-1) mg/day in the repaglinide group and 2000 (+/-500) mg/day in the metformin group. Significant improvements in glycaemic control [glycated haemoglobin, fasting and 2-h postprandial plasma glucose (PPG)] were demonstrated in both treatment groups. The decrease in PPG was significantly greater in the repaglinide group (P<0.05). During the treatment period, fasting plasma insulin (FPI) decreased significantly in both groups, more so with metformin (P<0.05). Two-hour postprandial plasma insulin (PPI) levels decreased only in the metformin group (P<0.05). Significant improvements between baseline and final visit were demonstrated in one or both groups in the following cardiovascular risk factors: total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, plasminogen activator inhibitor, lipoprotein(a) and homocysteine. No changes were observed in high-density lipoprotein cholesterol (HDL-C), apolipoprotein A-I, apolipoprotein B, fibrinogen, body mass index (BMI) or blood pressure.
The use of repaglinide or metformin in drug therapy-nai;ve patients with type 2 diabetes over a 12-month period is associated with improvements in both glycaemic control and cardiovascular risk profile. The latter cannot necessarily be attributed to the pharmacotherapy per se, but provides reassurance in the context of initiating oral hypoglycaemic drug therapy with these agents.
比较瑞格列奈或二甲双胍治疗12个月的2型糖尿病患者的血糖控制情况和心血管风险状况。
这是一项开放的非对照随机研究,纳入了112例2型糖尿病控制不佳且未接受过口服降糖药治疗的患者。开始使用瑞格列奈或二甲双胍治疗的患者进入为期8周的滴定期(以优化剂量:瑞格列奈,2 - 4毫克/天;二甲双胍,1500 - 2500毫克/天),随后是12个月的治疗期。在基线和治疗期结束时测定血糖控制情况和心血管危险因素。
瑞格列奈组的平均(标准差)最终药物剂量为3(±1)毫克/天,二甲双胍组为2000(±500)毫克/天。两个治疗组的血糖控制[糖化血红蛋白、空腹及餐后2小时血糖(PPG)]均有显著改善。瑞格列奈组的餐后血糖降低幅度显著更大(P<0.05)。治疗期间,两组的空腹血浆胰岛素(FPI)均显著降低,二甲双胍组降低更明显(P<0.05)。仅二甲双胍组的餐后2小时血浆胰岛素(PPI)水平降低(P<0.05)。以下心血管危险因素在一组或两组中从基线到末次访视有显著改善:总胆固醇、低密度脂蛋白胆固醇(LDL-C)、甘油三酯、纤溶酶原激活物抑制剂、脂蛋白(a)和同型半胱氨酸。高密度脂蛋白胆固醇(HDL-C)、载脂蛋白A-I、载脂蛋白B、纤维蛋白原、体重指数(BMI)或血压无变化。
在未接受过药物治疗的2型糖尿病患者中,使用瑞格列奈或二甲双胍进行为期12个月的治疗,可改善血糖控制情况和心血管风险状况。后者不一定归因于药物治疗本身,但在开始使用这些药物进行口服降糖药治疗时可提供一定保障。