Derosa Giuseppe, Fogari Elena, Cicero Arrigo F G, D'Angelo Angela, Ciccarelli Leonardina, Piccinni Mario N, Pricolo Fabio, Salvadeo Sibilla A T, Gravina Alessia, Ferrari Ilaria, Fogari Roberto
Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.
Hypertens Res. 2007 May;30(5):387-94. doi: 10.1291/hypres.30.387.
The aim of the study was to assess the effects of the combination of metformin plus pioglitazone or rosiglitazone on glucose and blood pressure in type 2 diabetic patients with metabolic syndrome, as well as its tolerability in those patients. In this 12-month, multicentric, double-blind, randomized, controlled, parallel-group trial, all patients began with metformin. Patients were randomized for self-administration of either pioglitazone or rosiglitazone for 12 months. We assessed body mass index (BMI), glycemic control (glycosylated hemoglobin [HbA(1c)], fasting and postprandial plasma glucose and insulin levels [FPG, PPG, FPI and PPI, respectively] and homeostasis model assessment [HOMA] index) and systolic and diastolic blood pressure (SBP and DBP, respectively), at baseline and at 3, 6, 9 and 12 months of treatment, as well as high-sensitivity C-reactive protein (hs-CRP), nitrites/nitrates and adiponectin (ADN) at baseline and at 12 months of treatment. Significant HbA(1c) decreases were obtained after 9 (p<0.05) and 12 (p<0.01) months in both groups. After 9 and 12 months, mean FPG and PPG levels were decreased in both groups (p<0.05 and p<0.01, respectively). We observed decreases in FPI and PPI at 9 and 12 months (p<0.05 and p<0.01, respectively) compared to the baseline values in both groups. Furthermore, HOMA index improvement over the baseline value was obtained only at 12 months (p<0.05) in both groups. SBP and DBP improved significantly (p<0.05, for each) in both groups after 12 months. hs-CRP decreased significantly (p<0.05) in both groups after 12 months; nitrites/nitrates and ADN increased significantly (p<0.05, for each) in both groups after 12 months. The combination of thiazolinediones and metformin is associated with a slight but significant improvement in the long-term blood pressure control of these patients, and with an improvement in the anti-inflammatory state, both of which are related to a similar reduction in insulin-resistance.
本研究旨在评估二甲双胍联合吡格列酮或罗格列酮对伴有代谢综合征的2型糖尿病患者血糖和血压的影响，以及这些患者对该联合用药的耐受性。在这项为期12个月的多中心、双盲、随机、对照、平行组试验中，所有患者均以二甲双胍起始治疗。患者被随机分组，自行服用吡格列酮或罗格列酮12个月。我们在基线时以及治疗的3、6、9和12个月时评估了体重指数（BMI）、血糖控制情况（糖化血红蛋白[HbA(1c)]、空腹和餐后血浆葡萄糖及胰岛素水平[分别为FPG、PPG、FPI和PPI]以及稳态模型评估[HOMA]指数）和收缩压及舒张压（分别为SBP和DBP），同时在基线时以及治疗的12个月时评估了高敏C反应蛋白（hs-CRP）、亚硝酸盐/硝酸盐和脂联素（ADN）。两组在治疗9个月（p<0.05）和12个月（p<0.01）后HbA(1c)均显著下降。在9个月和12个月后，两组的平均FPG和PPG水平均下降（分别为p<0.05和p<0.01）。与两组的基线值相比，我们观察到在9个月和12个月时FPI和PPI下降（分别为p<0.05和p<0.01）。此外，两组仅在12个月时HOMA指数相对于基线值有所改善（p<0.05）。12个月后两组的SBP和DBP均显著改善（每组p<0.05）。12个月后两组的hs-CRP均显著下降（p<0.05）；12个月后两组的亚硝酸盐/硝酸盐和ADN均显著升高（每组p<0.05）。噻唑烷二酮类药物与二甲双胍联合使用与这些患者的长期血压控制略有但显著改善相关，并且与抗炎状态改善相关，这两者均与胰岛素抵抗的类似降低有关。
