A Multicenter, Prospective, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4mg Compared with Placebo in Type 2 Diabetes Mellitus Patients Having Hypertriglyceridemia Not Controlled with Atorvastatin Therapy (PRESS VI)

作者：Jani Rajendrakumar H^*; Pai Vikas; Jha Pramod; Jariwala Gunjan; Mukhopadhyay Satinath; Bhansali Anil; Joshi Shashank

来源：Diabetes Technology & Therapeutics, 2014, 16(2): 63-71.

DOI：10.1089/dia.2013.0253

Background: Dyslipidemia due to diabetes is characterized by hypertriglyceridemia and reduced levels of high-density lipoprotein cholesterol (HDL-C) and elevated or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM). The objectives of this Phase III study were to evaluate the safety, tolerability, and efficacy of saroglitazar (ZYH1) 2-mg and 4-mg tablets (Lipaglyn; Zydus Cadila, Ahmedabad, India) compared with placebo in patients with diabetic dyslipidemia who are not controlled with atorvastatin 10mg therapy. Subjects and Methods: This was a 16-week prospective, multicenter, randomized, double-blind, placebo controlled, three-arm Phase III study in subjects with hypertriglyceridemia (>200 and <500mg/dL) with T2DM not controlled with atorvastatin 10mg. The study consisted of a run-in period of 4 weeks of life-style modification followed by 12 weeks of treatment with saroglitazar (2-mg or 4-mg) or placebo tablets. The primary end point was the change in plasma triglyceride level compared with baseline and the placebo arm at the end of Week 12. The secondary exploratory end points were change in lipid profile and fasting plasma glucose at Week 12. In total, 302 subjects were randomized to receive one of the treatments, saroglitazar 2mg (n=101) or saroglitazar 4mg (n=99), or matching placebo (n=102). Patients who received study medication and had undergone at least one post baseline efficacy evaluation were included in the efficacy analysis. Results: At Week 12, saroglitazar 2-mg and 4-mg tablets significantly reduced mean plasma triglyceride levels by -45.53.03% and -46.7 +/- 3.02% (mean +/- SE), respectively, and the difference was significant (P<0.001) compared with placebo. Saroglitazar 2mg demonstrated significant decrease in levels of non-HDL-C, very LDL-C, total cholesterol, and fasting plasma glucose. Additionally, saroglitazar 4mg also significantly reduced LDL-C and apolipoprotein B levels. Saroglitazar was found to be safe and well tolerated by patients. Conclusions: Saroglitazar appeared to be an effective and safe therapeutic option for improving hypertriglyceridemia in patients with T2DM.

• 出版日期2014-2-1
• 单位河北医科大学