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Saroglitazar

Saroglitazar is a peroxisome proliferator-activated receptor (PPAR) inhibitor used to manage and control high cholesterol in people with diabetes (diabetic dyslipidemia). It aids in managing high cholesterol, especially triglycerides, and elevated blood glucose levels in people with type 2 diabetes. Saroglitazar is an insulin sensitiser and a first-in-class drug that acts as a dual PPAR agonist at the subtypes α (alpha) and γ (gamma) of the PPAR.

Uses of Saroglitazar

The primary function of saroglitazar is managing dyslipidemia (elevated blood lipid levels) in patients with type 2 diabetes mellitus. Its dual mechanism of action targets both lipid and glucose abnormalities, making it a valuable therapeutic option. The key saroglitazar uses include:

  • Diabetic Dyslipidemia: Doctors generally recommend saroglitazar for treating diabetic dyslipidemia, a condition characterised by elevated triglyceride levels, low HDL (good) cholesterol, and high LDL (bad) cholesterol in those affected with type 2 diabetes.
  • Hypertriglyceridemia: Saroglitazar is effective in reducing elevated triglyceride levels, a common lipid abnormality associated with an increased risk of cardiovascular diseases.
  • Improving Glycemic Control: In addition to its lipid-lowering effects, saroglitazar also helps improve glycemic control by reducing HbA1c levels (a measure of long-term blood sugar control).
  • Non-Alcoholic Fatty Liver Disease (NAFLD): Saroglitazar has shown promising results in the management of NAFLD, a condition characterised by fat aggregation in the liver cells. It can progress to more severe conditions like non-alcoholic steatohepatitis (NASH).
  • Potential Use in Metabolic Syndrome: Due to its dual action on lipid and glucose metabolism, saroglitazar may also help manage metabolic syndrome, a cluster of ailments that increase the risk of cardiovascular disease and type 2 diabetes.

How to Use Saroglitazar

Most doctors recommend a dose of 4 mg per day, taken orally before the first meal of the day. Saroglitazar is available as uncoated tablets, each containing either 4 mg or 2 mg of the active ingredient.

Administration

  • Take saroglitazar precisely as your doctor prescribed.
  • Take the entire tablet with a glass of water. Avoid crushing, chewing, or breaking the tablet.
  • It is advisable to take saroglitazar before the first meal of the day.

Side Effects of Saroglitazar Tablet

Saroglitazar is generally well-tolerated; most patients do not experience significant side effects when taken at the recommended dosage. However, the following are some common side effects:

Generally, saroglitazar does not cause hypoglycaemia (low blood sugar levels). However, in some patients, hypoglycaemic episodes may occur, necessitating an adjustment of the daily insulin dose under the guidance of a consulting physician. 

Precautions

When taking saroglitazar, it is essential to consider the following precautions:

  • Saroglitazar should be used with caution in patients with liver and kidney disease
  • Patients with a history of cardiovascular disease should use saroglitazar cautiously. 
  • While saroglitazar primarily affects lipid levels, it can also influence blood glucose levels. Monitor blood sugar levels regularly, especially if taken with other antidiabetic medications.

How Saroglitazar Works

It is a dual peroxisome proliferator-activated receptor (PPAR) agonist, meaning it activates both PPAR-α and PPAR-γ receptors. This dual mechanism of action allows saroglitazar to exert its therapeutic effects on lipid and glucose metabolism:

Can I take Saroglitazar with Other Medicines?

Saroglitazar can potentially interact with certain medications, and it is essential to consult with a doctor before taking it in combination with other drugs. Here are some important considerations regarding the concomitant use of saroglitazar with other medicines:

  • Antidiabetic Medications: When saroglitazar is taken with other antidiabetic medications, such as metformin, sulfonylureas, or insulin, there is an increased chance of hypoglycaemia (low blood sugar levels). Patients should closely monitor their blood sugar levels and adjust the dosage of their antidiabetic medications as their doctor recommends.
  • Cholesterol-Lowering Medications: Saroglitazar may enhance the effects of cholesterol-lowering medications, such as statins or fibrates. This combination can increase the risk of muscle-related side effects, including myopathy (muscle weakness) and rhabdomyolysis (breakdown of muscle fibres). 
  • Blood Thinners: Saroglitazar may interact with blood thinners, such as warfarin, increasing the risk of bleeding. When taking saroglitazar with blood thinners, regular monitoring of blood clotting parameters, such as the international normalised ratio (INR), is recommended.
  • Medications Metabolised by CYP Enzymes: Saroglitazar is metabolised by the cytochrome P450 (CYP) enzyme system, specifically CYP2C8 and CYP3A4. Medications that inhibit or induce these enzymes may alter the metabolism and blood levels of saroglitazar, potentially increasing or decreasing its therapeutic effects.

Dosing information

Doctors generally recommend 4 mg per day, taken orally before the day's first meal. Saroglitazar is available as uncoated tablets, each containing either 4 mg or 2 mg of the active ingredient. It is crucial to take saroglitazar as your doctor advises and follow the prescribed dosage regimen. 

FAQs

1. Is Saroglitazar safe?

Saroglitazar is generally considered safe and well-tolerated by patients. Some minor side effects are weakness, fever, stomach inflammation, nausea, vomiting, chest pain, dizziness, gastritis, asthenia (lack of strength or energy), and pyrexia (fever). However, these side effects are typically mild and manageable.

2. Is saroglitazar good for fatty livers?

Yes, saroglitazar has shown promising results in the management of non-alcoholic fatty liver disease (NAFLD) & non-alcoholic steatohepatitis (NASH). Studies have demonstrated that saroglitazar can improve liver enzymes, reduce liver fat content, and decrease liver stiffness in patients with NAFLD and NASH. 

3. How long can you take saroglitazar?

Your doctor typically determines the duration of your saroglitazar treatment based on your condition and medication response. 

4. Is saroglitazar drug good for kidneys?

Saroglitazar is generally not associated with adverse effects on renal function or kidney damage. However, as a precautionary measure, the doctors remain cautious while initiating saroglitazar treatment in patients with abnormal renal function.

5. Can Saroglitazar cause hypoglycaemia?

Saroglitazar itself does not typically cause hypoglycaemia (low blood sugar levels). However, in some patients taking sulfonylureas or insulin for diabetes management, hypoglycaemic episodes may occur. In such cases, the daily insulin dose may need adjustment under the guidance of a doctor. 

6. Does Saroglitazar cause weight loss?

Saroglitazar is primarily used to manage diabetic dyslipidemia and hypertriglyceridemia in type 2 diabetes patients. While it mainly targets lipid and glucose levels, some patients may experience weight loss as a secondary effect. However, weight loss is not its primary function.

7. When should Saroglitazar tablets be taken?

Doctors generally recommend taking tablet saroglitazar before the day's first meal. However, it is essential to adhere to your doctor's guidelines and take saroglitazar as prescribed without adjusting the dosage or stopping the medicine without consulting them first.