AT AACE 2015
NASHVILLE (FRONTLINE MEDICAL NEWS) – Saroglitazar, currently approved for use in India only, is effective and safe for treating diabetic dyslipidemia and has been shown to be a potent agent for managing levels of triglycerides, cholesterol, glucose, and hemoglobin A1c.
This is according to a postmarketing surveillance study presented by Dr. Shashank Joshi, whose endocrinology clinic in Mumbai was involved in a 9-month trial to test the safety and efficacy of once-daily 4-mg doses of Saroglitazar on a population with diabetic dyslipidemia. Saroglitazar, manufactured by Zydus, is the first dual-PPAR (peroxisome proliferator-activated receptor) alpha and gamma agonist available commercially anywhere in the world, and has been approved only in India and on the market in that country for 20 months.
“[Saroglitazar] is fundamentally not structurally similar to a glitazone, [nor] to a fibrate, and it’s also not structurally similar to other glitazars, which have been investigated,” explained Dr. Joshi, who added that all phase III studies of saroglitazar have been published. “We [also] know diabetic dyslipidemia is very prevalent in the Indian population, shown predominantly [by] low HDL, high triglycerides, and high LDL.”
A total of 787 diabetic dyslipidemia patients were included in the study, all of whom were evaluated for lipid and glycemic parameters at baseline. The mean age of subjects was 53 years, mean weight was 73.9 kg, and 507 subjects (64.4%) were male. All subjects underwent follow-ups at 3, 6, and 9 months after baseline.
Mean triglyceride, LDL cholesterol, non-HDL cholesterol, and total cholesterol levels all showed significant reductions: Triglycerides dropped 43.8% from 297.9 mg/dL to 156.1 mg/dL, LDL levels dropped 18.5% from 132.5 mg/dL to 100.5 mg/dL, non-HDL levels dropped 29.7% from 199 mg/dL to 131.9 mg/dL, and total cholesterol levels dropped 23.1% from 239.9 mg/dL to 176.6 mg/dL (P <.001 for all).
Significant reductions were also seen in HbA1c levels (8.5% to 7%), fasting glucose levels (171.6 mg/dL to 116.4 mg/dL), and postprandial glucose levels (244.6 mg/dL to 149.7 mg/dL) (P <.001 for all). Furthermore, HDL levels improved by 12.7%, over the 9-month period, going from 41 mg/dL to 44.5 mg/dL.
Seven hundred and twenty-two subjects (91.7%) were on an antidiabetic medication at baseline, the most common of which were metformin (73.7%), sulfonylureas (58.3%), dipeptidyl peptidase–4 inhibitors (26.2%), and insulin (17.4%). More than half of these patients (365; 50.6%) were on dual therapy, 195 (27%) were on triple therapy, 135 (18.7%) were on monotherapy, and 27 (3.7%) of these subjects were taking more than three drugs at baseline. Of the 787 in the total population, 395 (50.2%) were on statins, the most common of which was atorvastatin (71%).
“[Saroglitazar] was well tolerated over a long term of 9 months, with no weight gain and edema, and no serious adverse events reported,” said Dr. Joshi, who also acknowledged potential limitations of the trial because of its being an ongoing, prospective study.
Dr. Joshi disclosed relationships with Zydus, maker of saroglitazar, and numerous other pharmaceutical companies.
