The Clinical Aspects of Saroglitazar and its Side Effects

  • Vadlamudi Naga Ratna Sai Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India
  • Sreenivas Pasula Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India
  • Sheelam Sumathi Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India
  • Mondra Sreekanth Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India
  • A. Srinivas Rao Department of Pharmacology, Bhaskar Pharmacy College, Moinabad, Hyderabad, India
  • Beda Durga Prasad Department of Chemistry, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Abstract

The new substance element has been known as novel antidiabetic drug, eg: saroglitazar. saroglitazar is a medication used to treat type-2 diabetes. saroglitazar was known under the exchange name Lipaglyn, created by Zydus cadila. lipaglyn is the first drug approved to treat type-2diabetes mellitus by the drug controller general of India in june 2013. Lipaglyn is demonstrated for the patients experiencing diabetes dyslipidaemia. It is given once daily for treatment. Saroglitazar manages the lipid parameters just as glycemic control. [1]


Keywords: Anti-diabetic, dual PPAR agonist, glitazar, hypertriglyceridemia, insulin sensitizer, Lipaglyn, AE’s (adverse effects).

Keywords: Anti-diabetic, dual PPAR agonist, glitazar, Lipaglyn

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Author Biographies

Vadlamudi Naga Ratna Sai, Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Sreenivas Pasula, Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Sheelam Sumathi, Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Mondra Sreekanth, Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Pharm D Department of Pharmacy Practice, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

A. Srinivas Rao, Department of Pharmacology, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Department of Pharmacology, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Beda Durga Prasad, Department of Chemistry, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

Department of Chemistry, Bhaskar Pharmacy College, Moinabad, Hyderabad, India

References

[1]: Agarwal R. The First approved agent in the Glitazar's Class: Saroglitazar, PubMed.gov,. 2014; 5(2)
[2]: Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study). Lancet. 2004; 364: 937-952.
[3]: La Rosa JC, He J, Vupputuri S. Effect of statins on risk of coronary disease: A meta-analysis of randomized controlled trials. JAMA. 1999; 282: 2340-2346.
[4]: Joshi SR, Anjana RM, Deepa M, et al. Prevalence of dyslipidemia in urban and rural India: The ICMR–INDIAB Study. PLOS ONE. 2014; 9(5): 96808.
[5]: Baigent C, Keech A, Kearney PM, et al. Cholesterol treatment trialists (CTT) collaborators. Efficacy and safety of cholesterol lowering treatment: Prospective meta-analysis of data from 90,056 participants in 14 randomized trials of statins. Lancet. 2005; 366: 1267-1278.
[6]: Cannon CP, Steinberg BA, Murphy SA, Mega JL, Braunwald E. Meta-analysis of cardiovascular outcomes trials comparing intensive versus moderate statin therapy. Journal of the American College of Cardiology. 2006; 483: 438-445.
[7]: Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004; 350: 1495-1504.
[8]: Adapted from HPS Collaborative Group. MRC/BHF Heart Protection Study of antioxidant vitamin supplementation in 20 536 high-risk individuals: A randomized placebo-controlled trial. Lancet. 2002; 360: 7-22.
[9]: Sacks FM, Tonkin AM, Shepherd J, et al. Effect of pravastatin on coronary disease events in subgroups defined by coronary risk factors, the prospective pravastatin pooling project. Circulation. 2000; 102: 1893-900. doi: 10.1161/01.CIR.102.16.1893
[10]: Miller M. Current perspectives on the management of hypertriglyceridemia. Am Heart J. 2000; 140: 232-240.
[11]. Fredenrich A, Grimaldi PA. PPAR delta. An uncompletely known nuclear receptor. Diabetes Metab. 2005; 31: 23-27.
12. Munigoti SP, Harinarayan CV. Role of glitazars in atherogenic dyslipidemia and diabetes: Two birds with one stone. Indian J Endocrinol Metab. 2014; 18(3): 283-287.
[13]: Jani H, Kansagra K, Jain MR, Patel H. Pharmacokinetics, safety, and tolerability of saroglitazar (ZYH1), a predominantly PPARα agonist with moderate PPARγ agonist activity in healthy human subjects. Clin Drug Investig. 2013; 33(11): 809-816.
[14]: Zydus Group launches new diabetic drug “The Times of India. Jun 6, 2013.
[15]: Lipaglyn (Saroglitazar) for Treating Hypertriglyceridemia in Type II Diabetes, India”. Drug Development and Technology. 2014; 8:132-141. 8.
[16]: [Internet]. Lipaglyn.com. 2018 [cited 19 September 2018].
[17]: Pai V, Paneerselvam A, Mukhopadhyay S, et al. 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 dyslipidemia (PRESS V). J Diabetes Sci Technol. 2014; 8(1):132-141.
[19]: Sosale et al, Saroglitazar for the treatment of hypertriglyceridemia in patients with type 2 diabetes: current evidence, Dove press 2015:8 189–196.
[18]: Jani R, Pai V, Jha P, et al. 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 hypertriglyceridemia not controlled with atorvastatin therapy (PRESS VI). Diabetes Technology & Therapeutics. 2014; 16(2): 63-71.
[20]: Manoria, PC, Chopra, HK, Parashar, SK, Dutta, AL, Pinto, B, Mullasari, A, Prajapati, S. "The nuances of atherogenic dyslipidaemia in diabetes: focus on triglycerides and current management strategies “. Indian Heart Journal. 65 (6): 68390.
[21]: Observational study of Effects of Saroglitazar on Glycaemic and Lipid Parameters on Indian Patients with Type 2 Diabetes “. SCIENTIFIC REPORTS.
[22]: Ramakrishnan, S. "-From 'Make in India 'to Made in India ': the saroglitazar story ". Indian Heart Journal. 67 (1): 8-10.
[23]: Shetty, SR, Kumar, S, Mathur, RP, Sharma, KH, Jaiswal, AD. "Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidaemia patients “. Indian Heart Journal. 67 (1): 23-6.
[24]: Munigoti, Srinivasa P, Harinarayan, CV. "Role of Glitazars in atherogenic dyslipidaemia and diabetes: Two birds with one stone? ". Indian Journal of Endocrinology and Metabolism. 2014; 18(3): 283-7.
[25]: Jani RH, Kansagra KK, Patel H. Pharmacokinetics, Safety and Tolerability of Saroglitazar (ZYH1), a Predominantly PPAR alpha Agonist with Moderate PPAR gamma Agonist Activity in Healthy Human Subjects. Clinical Drug Investigation, 2013; 33(11): 809–816
[26]: Sonu S. Biliary excretion of ZYH1 in wistar rats. Ahmedabad: Cadila Healthcare Ltd.; 2004.
[27]: Lipaglyn (Saroglitazar) [prescribing information]. Ahmedabad, India: Cadila Healthcare; 2013.
[28]: Jain MR et al, Dual PPAR Alpha/Gamma agonist saroglitazar improve liver histopathology and biochemistry in experimental NASH models. Liver Int. 2018;38(6):1084-94.
[29]: Shetty S, Kumar S, Mathur R, Sharma K, Jaiswal A. Observational study to evaluate the safety and efficacy of saroglitazar in Indian diabetic dyslipidemia patients. Indian Heart Journal. 2015; 67(1): 23-26.
[30]: Joshi S, Sound R, Saboo B. Efficacy and Safety of Saroglitazar in Indian Diabetics-two year data. Adapted from ADA 2016;
31. Bhatia V, Arora P, Kaur G, Kaul U. Saroglitazar: A New Drug to Treat. Res Open J. 2016; 4(1): 12-17. doi: 10.17140/HROJ-4-135
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1.
Ratna Sai VN, Pasula S, Sumathi S, Sreekanth M, Rao AS, Prasad BD. The Clinical Aspects of Saroglitazar and its Side Effects. JDDT [Internet]. 15Mar.2020 [cited 9Apr.2020];10(2):208-12. Available from: http://jddtonline.info/index.php/jddt/article/view/3941