Real Time Clinical Efficacy And Safety Of Saroglitazar In Diabetic Dyslipidemia 

Background: 
Dyslipidemia, a cardiovascular risk factor, is one of the most common comorbidity associated with type 2 diabetes(T2D). Diabetes and dyslipidemia go hand in hand in Indian population with almost 90% of diabetes patients have an associated atherogenic dyslipidemia characterized by the triad of increased triglyceride (TG) levels, low levels of high density lipoprotein (HDL-C) and higher proportion of small dense, low density lipoprotein cholesterol (sd-LDL-C). Saroglitazar is a dual PPAR α/γ agonist, approved in India for treatment of hypertriglyceridemia in type 2 diabetes not controlled with statins alone. 

Aims: 
This is a post-marketing surveillance study conducted with the objective to evaluate the efficacy and safety of saroglitazar 4mg once daily in patients with diabetic dyslipidemia in clinical practice.

Methods: 
This is an ongoing, observational, single-center, single-arm study. A total of 100 patients with T2D (with on-going antidiabetic and statin medications), age above 18 years, and triglycerides >200 mg/dL were prescribed saroglitazar 4mg once daily. This is an interim analysis of the results from 50 patients who completed their 3 month follow-up after treatment with saroglitazar. 

Results:
The mean age of these 50 diabetic dyslipidemia patients is 54.54 ±15.93 years with 60% (n=30) male participants and the average body weight of participants is 73.38 ± 12.43 kg. At baseline, all patients were on one or more anti-diabetic medication and statins. At 3 months follow-up, saroglitazar treatment showed significant reduction in TG from 322.6± 80.74 mg/dL at baseline to 151.76± 15.54 mg/dL (p <0.0001). Other lipid parameters like non HDL-C, HDL-C, LDL-C and total cholesterol (TC) also improved significantly (refer to the Table). Saroglitazar in combination with other anti-diabetics showed a significant absolute reduction of 0.8% in HbA1c (from 7.69±1.32 to 6.89±0.65, p <0.0001) at the end of 3 months follow up, with significant improvements in fasting (FPG) and postprandial plasma glucose (PPG) levels as well (refer to the Table).
No serious adverse events, alteration in liver or renal enzymes and edema or weight gain were reported.

Discussion: 
Saroglitazar is a potential therapeutic option in type 2 diabetic patients with high     triglyceride levels, not controlled by statins, for comprehensive control of lipid and glycemic parameters with acceptable safety profile. 

Table: Change in lipid and glycemic parameters after 3 months follow up. (Values are in mean ± SD.)

Lab Parameters	                    Baseline	                    3 months	                p  value

Lipids:
Triglycerides (mg/dL)	       322.6± 80.74	              151.76± 15.54	       p <0.0001
LDL-C (mg/dL)	               135.16±21.77	      107.9±14.59	               p <0.0001
HDL-C (mg/dL)	               35.82±5.04	              39.06±3.11	               p <0.0001   
TC (mg/dL)	                       234.8±23.98	              177.26±15.65	       p <0.0001
Non- HDL-C (mg/dL)	       199.7±22.99	              138.2±15.92	               p <0.0001

Glycemic:		
HbA1c (%)	                       7.688±1.32	              6.888± 0.65	               p <0.0001
FPG (mg/dL)	                       146.68±45.01	      103.6±17.85	               p <0.0001
PPG (mg/dL)	                       234.8±86.39	              149.04±32.37	       p <0.0001


References:

1. Parikh RM, Mohan V. Diabetes & Metabolic Syndrome. Clinical Research & Reviews 2010; 4: 10–12.
2. Taskinen MR. Diabetic dyslipidemia. Atheroscler Suppl.2002 May; 3(1):47-51.
3. Joshi SR. Saroglitazar for the treatment of dyslipidemia in diabetic patients. Expert Opin. Pharmacother. (2015); 16(4):597-606

Real time clinical efficacy and safety of saroglitazar in diabetic dyslipidemia