New PPAR Agonist Lowers CHO Levels Where Statins Don’t Work

Participants saw a 43.8% reduction in triglycerides…

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Type 2 diabetes patients in India showed declines in their A1C, fasting glucose, triglycerides and non-HDL cholesterol levels after nine months of daily treatment of saroglitazar, a dual peroxisome proliferator-activated receptor-a/y agonist. The findings, presented at the American Association of Clinical Endocrinologists meeting, also revealed that the drug did not cause any serious adverse events and was well tolerated by the patients.

Saroglitazar can significantly improve HbA1C and glucose levels while also lowering triglycerides after continued use in patients with type 2 diabetes, all with no impact on the patients’ weight, according to study findings.

The researchers analyzed data from 787 patients (507 male; mean age 53 years) at 54 sites in India who were prescribed 4 mg of saroglitazar daily for treatment of diabetic dyslipidemia. Within the cohort, 50.2% of participants (n = 395) were taking statin drugs and 91.7% of patients (n = 722) were taking ongoing anti-diabetic medications. Researchers evaluated lipid and glycemic parameters at baseline and again at 3, 6, and 9 months of follow-up.

Saroglitazar was approved and launched in India in September 2013 as Lipaglyn (Zydus Cadila, India) for treatment of diabetic dyslipidemia and hypertriglyceridemia uncontrolled by statins. It is not available in the United States. The post-marketing, multicenter, observational prospective study is the first of its kind in patients with diabetic dyslipidemia.

Participants saw a 43.8% reduction in triglycerides (297.9 mg/dl to 156.1 mg/dl) and a 29.7% drop in non-HDL cholesterol (199 mg/dl to 131.9 mg/dl) after 9 months of treatment. HbA1C percentage also fell from 8.5% to 7% (P < .0001). Fasting glucose decreased 28.1% and post-prandial plasma glucose dropped by 35.2% (P < .0001). In a sub-group analysis of patients taking other anti-diabetic medications, HbA1C percentage decreased from 8.5 ± 1.35 at baseline to 7 ± .78 at the 9-month follow-up (P < .0001).

The drug was well tolerated and weight-neutral among participants. Saroglitazar is part of a fourth class of dual PPAR agonists which bind to both the a and y PPAR isoforms. Structurally, Joshi said, saroglitazar is not similar to any of the other so-called glitazars, all of which can cause edema and weight gain. It has a different chemical structure, making it different from fibrates and other glitizars.

Practice Pearls:

• Fasting glucose decreased 28.1% and post-prandial plasma glucose dropped by 35.2% (P < .0001).
• In a sub-group analysis of patients taking other anti-diabetic medications, HbA1C percentage decreased from 8.5 ± 1.35 at baseline to 7 ± .78 at the 9-month follow-up (P < .0001).
• Saroglitazar is not similar to any of the other so-called glitazars, all of which can cause edema and weight gain.

Joshi, S. 9 Month Safety and Efficacy of Saroglitazar in Diabetes Dyslipidemia. Presented at: AACE 24th Annual Scientific & Clinical Congress; May 13-17, 2014; Nashville, Tenn.