Derosa Giuseppe, Ragonesi Pietro Dario, Fogari Elena, Cicero Arrigo Francesco Giuseppe, Bianchi Lucio, Bonaventura Aldo, Romano Davide, Maffioli Pamela
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, 27100, Italy.
Fundam Clin Pharmacol. 2014 Apr;28(2):221-9. doi: 10.1111/fcp.12001. Epub 2012 Oct 8.
The aim of this study was to evaluate whether the positive effects of sitagliptin on glycemic control and insulin resistance were maintained also after 2 years of therapy and whether sitagliptin could be effective also in improving lipid profile. In this randomized, double-blind, placebo-controlled trial, 205 patients with type 2 diabetes in therapy with different antidiabetic drugs were randomized to add sitagliptin 100 mg once a day or placebo to their current therapy. We evaluated at the baseline and after 6, 12, 18, and 24 months the following parameters: body mass index, glycated hemoglobin (HbA1c ), fasting plasma glucose (FPG), postprandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (Tg). Sitagliptin, added to previously taken antidiabetic agents, proved to be effective in improving glycemic profile, reducing HbA1c by -17.5%, FPG by -12.7%, PPG by -20.5%. Regarding insulin resistance, sitagliptin decreased FPI by -8.3% and HOMA-IR by -20.0%, confirming that what have been already reported in short-term studies can be applied also after 2 years of treatment. Sitagliptin also reduced body weight by -4.3%. Our study also showed the positive effect of sitagliptin on lipid profile; in particular, sitagliptin decreased TC by -13.3%, LDL-C by -20.4%, and Tg by -32.3%, and also increased HDL-C by + 13.6%. Sitagliptin proved to be effective on glycemic profile and insulin resistance even after 2 years of therapy and to be effective in improving body weight and lipid profile.
本研究的目的是评估西他列汀对血糖控制和胰岛素抵抗的积极作用在治疗2年后是否依然存在，以及西他列汀在改善血脂谱方面是否也有效。在这项随机、双盲、安慰剂对照试验中，205例正在使用不同抗糖尿病药物治疗的2型糖尿病患者被随机分为两组，一组在其当前治疗方案基础上加用每日一次100毫克西他列汀，另一组加用安慰剂。我们在基线以及6、12、18和24个月后评估了以下参数：体重指数、糖化血红蛋白（HbA1c）、空腹血糖（FPG）、餐后血糖（PPG）、空腹血浆胰岛素（FPI）、稳态模型评估胰岛素抵抗指数（HOMA-IR）、总胆固醇（TC）、高密度脂蛋白胆固醇（HDL-C）、低密度脂蛋白胆固醇（LDL-C）、甘油三酯（Tg）。在先前服用的抗糖尿病药物基础上加用西他列汀被证明可有效改善血糖谱，使HbA1c降低17.5%，FPG降低12.7%，PPG降低20.5%。关于胰岛素抵抗，西他列汀使FPI降低8.3%，HOMA-IR降低20.0%，证实了短期研究中已报道的结果在治疗2年后同样适用。西他列汀还使体重降低了4.3%。我们的研究还显示了西他列汀对血脂谱的积极作用；特别是，西他列汀使TC降低13.3%，LDL-C降低20.4%，Tg降低32.3%，并使HDL-C升高13.6%。即使在治疗2年后，西他列汀在血糖谱和胰岛素抵抗方面仍被证明是有效的，并且在改善体重和血脂谱方面也有效。
