1. Observational Study of Saroglitazar on Metabolic Parameters in Indian Patients with Diabetic Dyslipidaemia – A Fifty Eight Weeks of Clinical Experience

Diabetes and Obesity International Journal ISSN: 2574-7770

. Diabetes Obes Int J. 2018, May 3(3): 000181

Background: Earlier we had reported results of our study of treatment with Saroglitazar, in a dose of 4 mg daily, for 14 weeks in 34 patients with diabetic dyslipidemia., and showed significant improvement in both glycemic and lipid parameters. We conducted this 58 weeks follow-up study in 158 patients to determine whether the improvement in glycemic and lipid parameters persisted in long-term follow-up and whether long-term therapy had any effect on the blood pressure, weight, renal and liver functions. Methods: We have studied follow-up data of 158 patients collected from the authors’ clinic databases and analyzed the effect of saroglitazar on metabolic parameters. Data of patients having both baseline and follow-up data were included in the analysis. The mean duration of follow-up was 58 weeks. Saroglitazar was prescribed at a dose of 4 mg daily, in accordance with approved indication and prescribing information, to patients of T2DM and having hypertriglyceridemia (serum TG level ≥150 mg/dl). Patients received treatment as per routine standard of care without any experimentation on any patient. The patients’ physical parameters (weight, blood pressure etc.), serum lipid profile and glycemic parameters (fasting plasma glucose, post-meal plasma glucose,HbA1C) were determined at baseline and at last follow-up visit. Results: After a mean study duration period of 58 weeks of 158 patients with diabetic dyslipidemia, there was significant reduction in triglycerides from 319.88 ± 178.75 mg/dl (mean ± SD) to 174.03 ± 113.62 mg/dl (reduction of 145.84 ± 186.59 mg/dl; p<0.001). Glycosylated hemoglobin (HbA1c) was reduced from 7.91 ± 1.53% (mean ± SD) to7.25 ± 1.38% (reduction of 0.65 ± 1.37%; p<0.001). Other lipid and glycemic parameters such as total cholesterol, low-density lipoprotein, non-high-density lipoprotein, triglyceride/HDLc ratio, fasting and postprandial plasma glucose were also significantly reduced. There were no major adverse events observed or, reported during the entire study period. Conclusion: Our long-term follow-up study showed that dual PPAR α+γ agonist, saroglitazar, could be an effective and safe therapeutic option in adult patients with diabetic dyslipidemia with a persistent and significant improvement in glycemic and lipid parameters and may confer an additional beneficial effect on blood pressure and liver function as well.
May 2018
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