COMPARATIVE STUDY OF EFFICACY AND SAFETY OF SAROGLITAZAR AND FENOFIBRATE IN DIABETIC DYSLIPIDEMIC PATIENTS
Main Article Content
Keywords
Diabetes mellitus, Diabetic dyslipidaemia, Fenofibrate, Saroglitazar
Abstract
Introduction: Dyslipidaemia associated with diabetes is marked by hypertriglyceridemia and decreased levels of high-density lipoprotein cholesterol (HDL-C) and raised or normal levels of low-density lipoprotein cholesterol (LDL-C) in type 2 diabetes mellitus (T2DM). This study compared the efficacy and safety of saroglitazar and fenofibrate in diabetic dyslipidemic patients attending tertiary care hospital.
Materials and Methods: This was a prospective, randomized, comparative, intervention study conducted for a period of 3 months in the patients with diabetic dyslipidaemia attending a tertiary care hospital. Patients were allocated randomly into 2 groups. Group A received one Saroglitazar 4 mg tablet after breakfast in conjunction with their routine anti diabetic drugs whereas Group B patients received one Fenofibrate 200 mg tablet after breakfast along with their routine anti diabetic drugs. Lipid profile, fasting blood glucose (FBG) and HbA1c were examined in patients on day 0 and after completion of 12 weeks. Throughout the course of treatment, they were asked to report and record any adverse event.
Result: At week 12,TG, Total Cholesterol, LDL-C and HbA1C levels decreased significantly and HDL-Cincreased significantly from their respective baseline values in both groups. particularly, the Saroglitazar group showed a more profound decrease in HbA1c, TG, Cholesterol, LDL-C, FBS and profound increase in HDL-C compared to the Fenofibrate group. 1out of 30 patients in Group Areported mild adverse events while 4out of 30 patients reported mild adverse events in Group B.
Conclusion: Hence, adding Saroglitazar to the drug regimen of patients with Diabetic Dyslipidemia can result in significant improvements in glycemic and lipid parameters with the added benefit of minimal side effects, demonstrating the efficacy and safety of Saroglitazar in the treatment of Diabetic Dyslipidaemia when compared to Fenofibrate.
Materials and Methods: This was a prospective, randomized, comparative, intervention study conducted for a period of 3 months in the patients with diabetic dyslipidaemia attending a tertiary care hospital. Patients were allocated randomly into 2 groups. Group A received one Saroglitazar 4 mg tablet after breakfast in conjunction with their routine anti diabetic drugs whereas Group B patients received one Fenofibrate 200 mg tablet after breakfast along with their routine anti diabetic drugs. Lipid profile, fasting blood glucose (FBG) and HbA1c were examined in patients on day 0 and after completion of 12 weeks. Throughout the course of treatment, they were asked to report and record any adverse event.
Result: At week 12,TG, Total Cholesterol, LDL-C and HbA1C levels decreased significantly and HDL-Cincreased significantly from their respective baseline values in both groups. particularly, the Saroglitazar group showed a more profound decrease in HbA1c, TG, Cholesterol, LDL-C, FBS and profound increase in HDL-C compared to the Fenofibrate group. 1out of 30 patients in Group Areported mild adverse events while 4out of 30 patients reported mild adverse events in Group B.
Conclusion: Hence, adding Saroglitazar to the drug regimen of patients with Diabetic Dyslipidemia can result in significant improvements in glycemic and lipid parameters with the added benefit of minimal side effects, demonstrating the efficacy and safety of Saroglitazar in the treatment of Diabetic Dyslipidaemia when compared to Fenofibrate.
References
1. Bodke H, Wagh V, Kakar G, WAGH V. Diabetes mellitus and prevalence of other comorbid conditions: a systematic review. Cureus. 2023; 15
2. Mithal A, Majhi D, Shunmugavelu M, Talwarkar PG, Vasnawala H, Raza AS. Prevalence of dyslipidemia in adult Indian diabetic patients: A cross sectional study (SOLID). Indian J Endocrinol Metab 2014; 18:642-7.
3. Athyros VG, Doumas M, Imprialos KP, Stavropoulos K, Georgianou E, Katsimardou A, et al. Diabetes and lipidmetabolism. Hormones. 2018; 17: 61-7.
4. Athyros VG, Doumas M, Imprialos KP, Stavropoulos K, Georgianou E, Katsimardou A, et al. Diabetes and lipidmetabolism. Hormones. 2018; 17: 61-7.
5. Parikh RM, Joshi SR, Menon PS, Shash NS. Prevalence and pattern of diabetic dyslipidaemia in Indian type2 diabetic patients. Diabetes Metab Syndr. 2010;4(1):10-2.
6. Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, et [6] al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American diabetes association and the American college of cardiology foundation. Diabetes Care. 2008;31(4):811-22.
7. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, et al. Effects of [7] long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366(9500):1849-61.
8. Rubenstrunk A, Hanf R, Hum DW, Fruchart JC, Staels B. Safety issues and prospects for future generations of PPAR modulators. Biochim Biophys Acta. 2007;1771(8):1065-81.
9. Seber S, Ucak S, Basat O, Altuntas Y. The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients. Diabetes Res Clin Pract. 2006;71(1):52- 58.
10. Agrawal R. The first approved agent in the Glitazar's Class: Saroglitazar. [10] Curr Drug Targets. 2014; 15:151-55.
11. Majumder A, Chatterjee S. Diabetic Dyslipidaemia - Role of Saroglitazar. Med chem. 2014;4:684-87.
12. Pai V, Paneerselvam A, Mukhopadhyay S, Bhansali A, Kamath D. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidaemia (PRESS V). J Diabetes Sci Technol. 2014;8:132-41
13. Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of Saroglitazar 2 and 4 mg compared with placebo in type 2 diabetes mellitus patients having hypertriglyceridaemia not controlled with atorvastatin therapy (PRESS VI). Diabetes Technol Ther. 2014;16:63-71.
14. Efficacy and safety of Saroglitazar and Fenofibrate in the treatment of diabetic dyslipidaemia: A pilot study ijpp Volume 67 • Issue 1 • January-March 2023
2. Mithal A, Majhi D, Shunmugavelu M, Talwarkar PG, Vasnawala H, Raza AS. Prevalence of dyslipidemia in adult Indian diabetic patients: A cross sectional study (SOLID). Indian J Endocrinol Metab 2014; 18:642-7.
3. Athyros VG, Doumas M, Imprialos KP, Stavropoulos K, Georgianou E, Katsimardou A, et al. Diabetes and lipidmetabolism. Hormones. 2018; 17: 61-7.
4. Athyros VG, Doumas M, Imprialos KP, Stavropoulos K, Georgianou E, Katsimardou A, et al. Diabetes and lipidmetabolism. Hormones. 2018; 17: 61-7.
5. Parikh RM, Joshi SR, Menon PS, Shash NS. Prevalence and pattern of diabetic dyslipidaemia in Indian type2 diabetic patients. Diabetes Metab Syndr. 2010;4(1):10-2.
6. Brunzell JD, Davidson M, Furberg CD, Goldberg RB, Howard BV, Stein JH, et [6] al. Lipoprotein management in patients with cardiometabolic risk: consensus statement from the American diabetes association and the American college of cardiology foundation. Diabetes Care. 2008;31(4):811-22.
7. Keech A, Simes RJ, Barter P, Best J, Scott R, Taskinen MR, et al. Effects of [7] long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (the FIELD study): randomised controlled trial. Lancet. 2005;366(9500):1849-61.
8. Rubenstrunk A, Hanf R, Hum DW, Fruchart JC, Staels B. Safety issues and prospects for future generations of PPAR modulators. Biochim Biophys Acta. 2007;1771(8):1065-81.
9. Seber S, Ucak S, Basat O, Altuntas Y. The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients. Diabetes Res Clin Pract. 2006;71(1):52- 58.
10. Agrawal R. The first approved agent in the Glitazar's Class: Saroglitazar. [10] Curr Drug Targets. 2014; 15:151-55.
11. Majumder A, Chatterjee S. Diabetic Dyslipidaemia - Role of Saroglitazar. Med chem. 2014;4:684-87.
12. Pai V, Paneerselvam A, Mukhopadhyay S, Bhansali A, Kamath D. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidaemia (PRESS V). J Diabetes Sci Technol. 2014;8:132-41
13. Jani RH, Pai V, Jha P, Jariwala G, Mukhopadhyay S. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of Saroglitazar 2 and 4 mg compared with placebo in type 2 diabetes mellitus patients having hypertriglyceridaemia not controlled with atorvastatin therapy (PRESS VI). Diabetes Technol Ther. 2014;16:63-71.
14. Efficacy and safety of Saroglitazar and Fenofibrate in the treatment of diabetic dyslipidaemia: A pilot study ijpp Volume 67 • Issue 1 • January-March 2023
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Published
Jan 09, 2025
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How to Cite
Dr. B. Srilatha, & Dr. Uday Kumar M. (2025). COMPARATIVE STUDY OF EFFICACY AND SAFETY OF SAROGLITAZAR AND FENOFIBRATE IN DIABETIC DYSLIPIDEMIC PATIENTS. Journal of Population Therapeutics and Clinical Pharmacology, 32(1), 115-119. https://doi.org/10.53555/kmjv5r69
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Author Biographies
Dr. B. Srilatha
Assistant professor, Department of Pharmacology, Government medical college, kamareddy, Telangana
Dr. Uday Kumar M
Assistant professor, Department of Pharmacology, Government medical college, kamareddy, Telangana
How to Cite
Dr. B. Srilatha, & Dr. Uday Kumar M. (2025). COMPARATIVE STUDY OF EFFICACY AND SAFETY OF SAROGLITAZAR AND FENOFIBRATE IN DIABETIC DYSLIPIDEMIC PATIENTS. Journal of Population Therapeutics and Clinical Pharmacology, 32(1), 115-119. https://doi.org/10.53555/kmjv5r69