Research Article Details
| Article ID: | A06680 |
| PMID: | 32782883 |
| Source: | Cureus |
| Title: | An Observational Study of Reduction in Glycemic Parameters and Liver Stiffness by Saroglitazar 4 mg in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease. |
| Abstract: | Background Metabolic abnormal conditions, such as diabetes and high triglycerides (TGs), are commonly associated with nonalcoholic fatty liver disease (NAFLD). Currently, there is no approved pharmacotherapy for NAFLD. Saroglitazar, the world's first approved dual peroxisome proliferator-activated receptors (PPAR) α and γ agonist, was approved in India for the treatment of diabetic dyslipidemia. The objective of this study was to observe the safety and effectiveness of saroglitazar, 4 mg once daily, in reducing glycemic parameters and liver fibrosis in type 2 diabetes mellitus (T2DM) patients with NAFLD.  Method In this prospective observational study, we enrolled 30 patients with T2DM and NAFLD (primarily detected by ultrasonography (USG) of the abdomen) who were treated with saroglitazar, 4 mg once daily, and the follow-up data were available for six months after saroglitazar treatment. During follow up, all patients were on stable antidiabetic and statin therapy. Liver stiffness was measured by FibroScan® (Echosens™ North America, Waltham, MA) elastography at baseline and at the six-month follow-up. Results At the six-month follow-up after saroglitazar treatment, significant improvement was observed in glycemic parameters, liver stiffness on FibroScan, and serum transaminase levels. The serum TG levels were significantly reduced with saroglitazar. No major adverse event was reported. Conclusion In this observational study of patients with T2DM and NAFLD, saroglitazar improved liver stiffness, as well as the glycemic and lipid parameters. A long-term randomized controlled clinical trial is required to further establish the safety and efficacy of saroglitazar in the treatment of T2DM and NAFLD. |
| DOI: | 10.7759/cureus.9065 |
| Strategy ID | Therapy Strategy | Synonyms | Therapy Targets | Therapy Drugs | |
|---|---|---|---|---|---|
| S03 | Anti-fibrosis | fibrosis | Angiotensin Receptor Blocker (ARB); CCR2/CCR5 antagonist; Thyroid receptor β agonist; PEGylated human FGF21 analogue; Monoclonal antibody to lysyl oxidase-like 2 (LOXL2); Galectin-3 inhibitor; FGF19 variant | Losartan; Cenicriviroc; VK-2809; MGL-3196; Pegbelfermin; Simtuzumab; GR-MD-02; NGM282 | Details |
| Target ID | Target Name | GENE | Action | Class | UniProtKB ID | Entry Name |
|---|
| Diseases ID | DO ID | Disease Name | Definition | Class | |
|---|---|---|---|---|---|
| I13 | 3146 | Lipid metabolism disorder | An inherited metabolic disorder that involves the creation and degradation of lipids. http://en.wikipedia.org/wiki/Lipid_metabolism | disease of metabolism/ inherited metabolic disorder | Details |
| I05 | 9352 | Type 2 diabetes mellitus | A diabetes that is characterized by chronic hyperglycaemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in insulin secretion, insulin action, or both. A diabetes mellitus that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. http://en.wikipedia.org/wiki/Diabetes, http://en.wikipedia.org/wiki/Diabetes_mellitus_type_2 | disease of metabolism/inherited metabolic disorder/ carbohydrate metabolic disorder/glucose metabolism disease/diabetes/ diabetes mellitus | Details |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress | |
|---|---|---|---|---|---|---|---|
| D321 | Saroglitazar | Chemical drug | DB13115 | PPARA agonist; PPARG agonist | Antidiabetic drug | Approved in India | Details |
| D579 | Emfilermin | Miscellany | -- | adipocytes | Enhance lipid metabolism | Under investigation | Details |
| D328 | Serine | Chemical drug | DB00133 | SRR | Improve insulin resistance | Under clinical trials | Details |
| D316 | S-adenosyl-L-methionine | Chemical drug | DB00118 | GNMT cofactor | Antiviral | Under clinical trials | Details |
| D094 | Cysteamine | Chemical drug | DB00847 | GSS stimulant | Renal drug | Under clinical trials | Details |
| D095 | Cysteamine bitartrate | Chemical drug | DB00847 | -- | -- | Under clinical trials | Details |