From the Research
Saroglitazar is not recommended for use in patients under 18 years of age. The safety and efficacy of this lipid-lowering medication have not been established in pediatric populations, so it should only be prescribed to adults 18 years and older. In elderly patients (typically those over 65 years), no specific age cutoff exists, but caution is advised as these patients may have reduced hepatic, renal, or cardiac function and are more likely to be taking concomitant medications. When prescribing saroglitazar, healthcare providers should consider starting at the lower end of the dosing range in elderly patients and monitor them more closely for adverse effects. The age restriction for saroglitazar is based on the lack of clinical trial data in pediatric populations and concerns about potential effects on growth and development in younger patients, as the drug affects lipid metabolism and PPAR pathways that may influence developmental processes 1.
Key Considerations
- The most recent study 1 supports the use of saroglitazar in adults with non-alcoholic fatty liver disease, with or without diabetes, including compensated cirrhosis.
- The study found significant improvements in liver stiffness measurement (LSM) and controlled attenuation parameter (CAP) values, as well as biochemical parameters, with minimal adverse effects.
- However, the study did not include pediatric patients, and therefore, the safety and efficacy of saroglitazar in this population remain unknown.
- As with any medication, healthcare providers should exercise caution when prescribing saroglitazar to elderly patients, due to potential age-related changes in hepatic, renal, or cardiac function.
Clinical Implications
- Saroglitazar may be a useful treatment option for adults with non-alcoholic fatty liver disease, with or without diabetes, including compensated cirrhosis.
- Healthcare providers should carefully monitor patients for adverse effects, particularly in elderly patients or those with underlying medical conditions.
- Further studies are needed to establish the safety and efficacy of saroglitazar in pediatric populations.