A RANDOMISED, PROSPECTIVE, PARALLELAND OPEN LABEL STUDY TO COMPARE EFFICACY AND SAFETY OF METFORMIN PLUS ROSUVASTATIN AND GLIMEPIRIDE PLUS ROSUVASTATIN IN PATIENTS OF COEXISTING NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD) AND TYPE 2 DIABETES MELLITUS (T2DM)

Abstract

Background and Objectives: NAFLD and T2DM has global prevalence of 55.5% with currently no approved treatment. There is insufcient data for its pharmacotherapy. The sharing of risk factors, most common being the insulin resistance between NAFLD and T2DM, makes the antidiabetic drugs, with effect on insulin resistance, the potential treatment options. The aim was to compare efcacy and safety of antidiabetic drugs i.e. Metformin and Glimepiride with concomitant Rosuvastatin in NAFLD coexistent with T2DM. Methods: Randomized, prospective, parallel and open-label study recruited 60 patients of concomitant NAFLD and T2DM after getting Institutional Review Board approval. Patients of either sex (20-60 years) with NAFLD (ultrasound diagnosed & raised AST 50-150 U/L) and T2DM(FBS> 126mg/dl) were recruited in medicine OPD after obtaining written informed consent. Chronic alcohol users and pregnancy cases were excluded. Patients were randomised into Group A[Rosuvastatin(10mg OD)+ Metformin(1gm BD)] & Group B[Rosuvastatin(10mg OD)+Glimepiride(3mg BD)]. Primary outcome was improvement in hepatic parameters and ultrasound grading of liver. Secondary outcomes were improvement in anthropometric, glycaemic and lipid parameters and assessment of safety. Results: Group A caused signicant(p<0.05) reduction in hepatic parameters(S.Bilirubin & AST). Group A and B showed non-signicant improvement(p>0.05) in ultrasound grading of liver, respectively (24% vs 20% patients). Intergroup difference was signicant(p<0.05) for weight and BMI in Group A. Both groups showed highly signicant(p<0.001) reduction in glycaemic parameters and signicant(p<0.05) reduction in lipid parameters. Both treatments were safe. Conclusion: Metformin plus Rosuvastatin seems to be more efcacious in NAFLD and T2DM over 90 days. These drugs could improve prognosis because of insulin sensitising action and additional benets in cancers, cardiovascular diseases. Further studies are required to strengthen these ndings which may help in nding a standard treatment for NAFLD and T2DM.