Bhosle Deepak, Bhosle Vandana, Bobde Jyoti, Bhagat Abhijeet, Shaikh Huzaif, Kadam Rajesh
Consultant Diabetologist.
Consultant Pathologist, Deogiri Diabetes Centre.
J Assoc Physicians India. 2018 Mar;66(3):14-7.
Patients with prediabetes are not only at increased risk of progression to type 2 diabetes, but they are also at high risk of developing cardiovascular risk compared to normoglycemic people. Further, prediabetes is also often associated with abnormal lipid levels (dyslipidemia). We therefore aimed to evaluate the effect of Saroglitazar in patients with prediabetes and dyslipidemia.
This was a prospective, single centre, single arm study involving patients with pre-diabetes and dyslipidemia. Subjects with baseline HbA1c 5.7-6.4% and dyslipidemia (Total cholesterol > 200mg/dl, LDL-C > 130 mg/dl, triglycerides > 150 mg/dl and HDL< 40 mg/dl) were enrolled in this study. Subjects with on-going medications affecting blood glucose or lipids were excluded from the study. Saroglitazar 4mg once daily was administered for a period of 24 weeks. The primary outcome was change in serum triglycerides and secondary outcome parameters included changes in other lipid parameters and HbA1c levels at 24 weeks follow-up.
Forty patients with prediabetes and dyslipidemia were enrolled in the study. At 24 weeks follow-up, serum triglycerides was significantly reduced from 348 ± 86.98 mg/dl to 216.4 ± 72.34 mg/dl (P <0.0001). HbA1c was significantly reduced from 6.3 ± 0.16 % to 5.5 ± 0.30 % after 24 weeks of Saroglitazar therapy (P<0.0001). There were significant improvements observed in other lipid parameters at 24 weeks follow-up period. Saroglitazar was found to be safe and well tolerated, no serious adverse event reported during entire study period.
Saroglitazar is safe and effective in prediabetes with dyslipidemia by exerting its dual lipid lowering and glycemic actions.
糖尿病前期患者不仅进展为2型糖尿病的风险增加，而且与血糖正常者相比，他们发生心血管疾病风险的可能性也很高。此外，糖尿病前期通常还与血脂异常（血脂紊乱）有关。因此，我们旨在评估沙罗格列扎对糖尿病前期和血脂异常患者的疗效。
这是一项前瞻性、单中心、单臂研究，纳入了糖尿病前期和血脂异常患者。基线糖化血红蛋白（HbA1c）为5.7 - 6.4%且伴有血脂异常（总胆固醇>200mg/dl、低密度脂蛋白胆固醇>130mg/dl、甘油三酯>150mg/dl以及高密度脂蛋白<40mg/dl）的受试者被纳入本研究。正在服用影响血糖或血脂药物的受试者被排除在研究之外。每天一次服用4mg沙罗格列扎，持续24周。主要结局是血清甘油三酯的变化，次要结局参数包括其他血脂参数的变化以及24周随访时的HbA1c水平。
40例糖尿病前期和血脂异常患者被纳入研究。在24周随访时，血清甘油三酯从348±86.98mg/dl显著降至216.4±72.34mg/dl（P<0.0001）。沙罗格列扎治疗24周后，HbA1c从6.3±0.16%显著降至5.5±0.30%（P<0.0001）。在24周随访期内，其他血脂参数也有显著改善。发现沙罗格列扎安全且耐受性良好，在整个研究期间未报告严重不良事件。
沙罗格列扎通过发挥其降低血脂和血糖的双重作用，对于伴有血脂异常的糖尿病前期患者是安全有效的。
