Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

SAROGLITAZAR (LIPAGLYN)

10,996 views

Published on

Saroglitazar, Lipaglyn

Published in: Health & Medicine

SAROGLITAZAR (LIPAGLYN)

  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 - http://www.theheart.org/documents/sitestructure/en/content/programs/12 *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

×