Davies Michael J, Merton Katherine W, Vijapurkar Ujjwala, Balis Dainius A, Desai Mehul
Janssen Scientific Affairs, LLC, Titusville, NJ, USA.
Janssen Research & Development, LLC, Raritan, NJ, USA.
Diabetes Metab Syndr Obes. 2017 Jan 27;10:47-55. doi: 10.2147/DMSO.S126291. eCollection 2017.
Metabolic syndrome refers to a collection of risk factors associated with the development of cardiovascular disease and type 2 diabetes mellitus (T2DM). Canagliflozin, a sodium glucose co-transporter 2 inhibitor, improves glycemic control and reduces body weight and blood pressure (BP) in a broad range of patients with T2DM. This post hoc analysis assessed the effects of canagliflozin on the components of metabolic syndrome in patients with T2DM and metabolic syndrome.
This analysis was based on data from 2 head-to-head studies of canagliflozin in patients with T2DM on background metformin versus glimepiride (study 1) and background metformin plus sulfonylurea versus sitagliptin 100 mg (study 2). Changes from baseline in glycemic efficacy, anthropometric measures, BP, and lipids were evaluated with canagliflozin versus glimepiride and sitagliptin at week 52 in patients who met ≥2 of the criteria for metabolic syndrome (in addition to T2DM): triglycerides ≥1.7 mmol/L; high-density lipoprotein cholesterol (HDL-C) <1.0 mmol/L (men) or <1.3 mmol/L (women); waist circumference ≥102 cm (non-Asian men), ≥88 cm (non-Asian women), >90 cm (Asian men), or >80 cm (Asian women); diagnosis of hypertension or meeting BP-related criteria (systolic BP ≥130 mmHg or diastolic BP ≥85 mmHg). Safety was assessed based on adverse event reports.
In study 1, canagliflozin 100 and 300 mg provided similar and greater HbA1c reductions versus glimepiride, respectively. In study 2, canagliflozin 300 mg provided greater HbA1c lowering versus sitagliptin 100 mg. Canagliflozin also reduced fasting plasma glucose, body weight, body mass index, waist circumference, BP, and triglycerides, and increased HDL-C and low-density lipoprotein cholesterol versus glimepiride and sitagliptin. Canagliflozin was generally well tolerated in each study.
Canagliflozin was associated with improvements in all components of metabolic syndrome in patients with T2DM and metabolic syndrome, whereas glimepiride and sitagliptin only improved glycemic components over 52 weeks.
代谢综合征是指与心血管疾病和2型糖尿病（T2DM）发生相关的一组危险因素。卡格列净是一种钠-葡萄糖协同转运蛋白2抑制剂，可改善血糖控制，并降低广泛的T2DM患者的体重和血压（BP）。这项事后分析评估了卡格列净对T2DM合并代谢综合征患者代谢综合征各组分的影响。
该分析基于两项头对头研究的数据，一项研究是卡格列净与格列美脲对比，T2DM患者以二甲双胍为基础用药（研究1）；另一项研究是卡格列净与西格列汀100 mg对比，T2DM患者以二甲双胍加磺脲类药物为基础用药（研究2）。在符合代谢综合征（除T2DM外）≥2项标准的患者中，于第52周评估卡格列净与格列美脲和西格列汀相比，血糖疗效、人体测量指标、血压和血脂相对于基线的变化：甘油三酯≥1.7 mmol/L；高密度脂蛋白胆固醇（HDL-C）<1.0 mmol/L（男性）或<1.3 mmol/L（女性）；腰围≥102 cm（非亚洲男性）、≥88 cm（非亚洲女性）、>90 cm（亚洲男性）或>80 cm（亚洲女性）；高血压诊断或符合血压相关标准（收缩压≥130 mmHg或舒张压≥85 mmHg）。根据不良事件报告评估安全性。
在研究1中，卡格列净100 mg和300 mg分别比格列美脲降低糖化血红蛋白（HbA1c）的幅度更大且相似。在研究2中，卡格列净300 mg比西格列汀100 mg降低HbA1c的幅度更大。与格列美脲和西格列汀相比，卡格列净还降低了空腹血糖、体重、体重指数、腰围、血压和甘油三酯，并提高了HDL-C和低密度脂蛋白胆固醇。在每项研究中，卡格列净总体耐受性良好。
卡格列净与T2DM合并代谢综合征患者代谢综合征的所有组分改善相关，而格列美脲和西格列汀在52周内仅改善了血糖组分。
