Diabetic Dyslipidaemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the “bad” low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the “good” high-density lipoprotein (HDL) cholesterol concentration in the blood. Optimal LDL cholesterol levels for adults with diabetes are less than 100 mg/dL, optimal HDL cholesterol levels are equal to or greater than 40 mg/dL, and desirable triglycerides levels are less than 150 mg/dL.Over 80 per cent of all diabetic patients are estimated to be suffering from diabetic dyslipidaemia. There are more than 350 million diabetics globally – so the people suffering from diabetic dyslipidaemia could be around 300 million.
Lipaglyn (Saroglitazar) is a new drug for treating Diabetic Dyslipidaemia or Hypertriglyceridemia in Type II diabetes, not controlled by statins alone.It is a non-thiazolidinedione and is the first therapy to be approved for this condition.
Lipaglyn was well tolerated and had a better safety profile than the comparators. Importantly Lipaglyn has a non-renal route of elimination, and did not show adverse events like edema, weight gain, myopathies or derangement of liver and/or kidney functions, thus making it safe and efficacious.
Mode of Action
Like all glitazars, saroglitazar acts as a dual PPAR agonist at the subtypes α (alpha) and γ (gamma) of the peroxisome proliferator-activated receptor(PPAR). Blocking PPARα lowers high blood triglycerides, and blocking PPARγ improves insulin resistance and consequently lowers blood sugar
Lipaglyn is recommended for once daily administration as 4 mg tablets.
It is shown that the 4 mg dose of Lipaglyn led to a reduction of triglycerides and LDL (bad) cholesterol, and an increase in HDL (good) cholesterol and also showed a reduction in Fasting Plasma Glucose and glycosylated haemoglobin (HbA1c) thereby confirming its beneficial effects of both lipid and glycemic control in diabetic patients.
Pharma major Zydus Cadila is registering Lipaglyn in other markets.Lipaglyn is the first Glitazar to be approved anywhere in the world. The company will be launching it in the Indian market by the end of third quarter and plans to introduce in the developed market in the next three to five years.
The drug has been approved for launch in India by the Drug Controller General of India (DCGI). With a novel action that offers lipid and glucose lowering effects in one molecule.
Zydus will offer a dedicated Lipaglyn support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time.
Lipaglyn is a prescription drug and can be taken only under the advice and guidance of a registered medical practitioner.