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Saroglitazar, Lipaglyn

Published in: Health & Medicine


  1. 1. LIPAGLYN (Saroglitazar) for DIABETIC DYSLIPIDEMIA Dr. T. Vijay bhushanam M.B.B.S, M.D
  2. 2. Objectives • Diabetic dyslipidemia – Components – Complications – Treatment – Need for novel treatment • LIPAGLYN (Saroglitazar) – Mechanism of action – Clinical trials. • Summary
  3. 3. Diabetic dyslipidemia Components 1. High Tryglycerides 2. Low HDL-c 3. Postprandial lipemia
  4. 4. Diabetic dyslipidemia Complications Hyperglycemia: – Macrovascular complications: • CVD – Microvascular complications: • Retinopathy, Nephropathy, Neuropathy Dyslipidemia: – Macrovascular complications • Hypertriglyceridemia in T2DM patients increases the CV risk by 3 times. – Microvascular complications • Hypertriglyceridemia in T2DM patients increases the risk of diabetic kidney disease by 2-folds.* * Sacks FM, Hermans MP, Fioretto P et al. Association between plasma triglycerides and HDL-cholesterol and microvascular kidney disease and retinopathy in type 2 diabetes: A global case-control study in 13 countries. Circulation 2013 Dec 18.
  5. 5. Diabetic dyslipidemia Treatment and Benefits • Glycemic control – Microvascular benefits: Well proven – Macrovascular benefits : Proven • PPAR-γ agonists: – Microvascular benefits : Well proven – Macrovascular benefits : Reduce CV end points (Death, MI, stroke) significantly (by 16-18%) in DM patients * • PPAR-α agonists: – Microvascular benefits : Prevent progression of early-stage diabetic retinopathy** – Macrovascular benefits : Proven ** * PROactive study. JA Dormandy et al, Lancet 2005; 366: 1279–89. Lincoff et al. JAMA 2007;298:1180-1188 ** FIELD study. Lancet 2007;370:1687-97. ACCORD Eye Study Group. New Engl J Med 2010;363:233-44. Fenofibrate: a new treatment for diabetic retinopathy. Molecular mechanisms and future perspectives. Curr Med Chem 2013; 20:3258-66.
  6. 6. Diabetic dyslipidemia What is needed in the management • Treating both Hyperglycemia and dyslipidemia is the comprehensive management of Diabetic dyslipidemia • Statins are the first line drugs for diabetic dyslipidemia, but still a significant proportion of residual risk (≈75%) remains, requiring add on therapies • PPAR agonists (α and γ) have hypolipidemic and antihyperglycemic effects with proven macro- and micro-vascular benefits, but there are concerns for safety
  7. 7. Diabetes. 2005 Aug;54(8):2460-70 Diabetic dyslipidemia What is needed in the management Dual PPAR-α/γ agonists
  8. 8. LIPAGLYN – Saroglitazar World’s first approved dual PPAR-α/γ agonist
  9. 9. Spectrum of PPAR activity of various agents : Each PPAR agonist is unique Adapted from - *Illustrative chart
  10. 10. Published Sept 2013 Clinical Drug Investigation
  11. 11. Phase 3: PRESS V Lipaglyn vs Pioglitazone in Diabetic dyslipidemia 11
  12. 12. Phase 3: PRESS V Lipaglyn Vs Pioglitazone: Safety assessment 13 Pai V et al. J Diabetes Sci Technol 16 Jan 2014
  13. 13. Critical Parameters Benefits Weight Gain • There was no increase in the weight in Lipaglyn group, • However Pioglitazone has shown an average increase of 1.6 kg Cardiovascular safety  2D Echo and ECG Examinations  No change in cardiac function  No edema observed Safety and Tolerance Lipaglyn demonstrated no significant change in : • LFT : (No DILI) • RFT: (Creatinine / eGFR) • CPK • Hemoglobin Phase 3: PRESS V Lipaglyn Vs Pioglitazone: Advantages
  14. 14. Phase 3: PRESS VI Lipaglyn Vs Placebo in Diabetic dyslipidemia on Atorvastatin 15
  15. 15. Phase 3: PRESS VI Lipaglyn Vs Placebo: Results Primary Efficacy end point: TG reduction Effect on other lab parameters
  16. 16. Phase 3: PRESS VI Lipaglyn Vs Placebo: Safety assessment
  17. 17. Phase 3: PRESS VI Lipaglyn Vs Placebo: Adverse events
  18. 18. Summary • Current standards of care for blood glucose, blood pressure and LDL-C leaves behind a high level of residual vascular risk, including microvascular and macrovascular complications. • Statin therapy alone is not sufficient for all-at risk patients (AACE response to AHA/ACC 2013 cholesterol guidelines) • Targeting Diabetic dyslipidaemia (High TG, High Non- HDL, Low HDL) with non statin therapies is required along with statins. • LIPAGLYN is the best available option with Hypolipidemic and Antihyperglycemic effects (↓TG, ↓Non-HDL, ↓HbA1C) and insulin sensitizing actions.
  19. 19. *The above values are as per International Standards Regular monitoring of blood sugars at home with the help of a glucometer is recommended and also maintenance of a SMBG (Self Monitoring of Blood Glucose) chart, which should be showed to your Diabetologist during every visit.
  20. 20. THANK YOU