NASHVILLE, Tenn. — 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 patient’s weight, according to study findings presented here.
Shashank Joshi, MD, FACP, FRCP, FACE, chair of the Indian chapter of AACE and president of the Indian Academy of Diabetes, said the drug, a first-in-class dual peroxisome proliferator-activated receptor (PPAR)-a/y agonist, may have a potential role in the management of metabolic syndrome.
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, Joshi said.
Joshi and colleagues 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.
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, Joshi said. No patients reported serious adverse events.
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,” Joshi said. “It’s a very unique compound from that standpoint.” – by Regina Schaffer
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.
Disclosure: Joshi reports no relevant financial disclosures.