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JARDIANCE: Newly Approved Drug to Lower HbA1C in Type-2 diabetes

JARDIANCE: Newly Approved Drug to Lower HbA1C in Type-2 diabetes. Presented By: Rahul Patel, MS, PharmD. C andidate 2015 Dr. Sam Shimomura, Associate Dean, Western University of Health Sciences Date:09/25/2014. Disclosure. I, Rahul Patel, have no conflict of interest to disclose.

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JARDIANCE: Newly Approved Drug to Lower HbA1C in Type-2 diabetes

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  1. JARDIANCE:Newly Approved Drug to Lower HbA1C in Type-2 diabetes Presented By: Rahul Patel,MS, PharmD. Candidate 2015 Dr. Sam Shimomura, Associate Dean, Western University of Health Sciences Date:09/25/2014

  2. Disclosure I, Rahul Patel, have no conflict of interest to disclose.

  3. Objectives • Pharmacists will be able to: • Describe SGLT2 inhibitors • Compare available SGLT-2 inhibitors • Identifyideal candidates for SGLT2 inhibitors

  4. Introduction1 • Diabetes mellitus is a chronic disease often requiring complex treatment regimens to prevent long-term complications. • According to the 2012 statistics from CDC, 29.1 million people have diabetes. • The total direct and indirect estimated cost of the disease in 2014 is 245 billion.

  5. Introduction (Cont’d) • Type 2 diabetes is characterized by 3 factors • Persistent hyperglycemia • Impaired β-cell function • Insulin resistance

  6. SGLT2 Inhibitors: A Novel Class2 • Sodium-Glucose Co-transporter 2 (SGLT-2) inhibition works directly on glucose, independent of β-cell function and insulin • 90% of the glucose is reabsorbed by SGLT2 , remaining 10% by SGLT1

  7. Currently Approved SGLT2 Inhibitors Invokana (canagliflozin) Mfg by: Janssen Pharmaceuticals, Inc. Licensed from Mitsubishi Tanabe Pharma Corporation Approved in Mar’2013 Farxiga (dapagliflozin) Mfg By: Bristol-Myers Squib Company Mkt By: AstraZeneca Pharmaceuticals LP Approved in Jan’2014 Jardiance (empagliflozin) Mfg By: Eli Lilly and Company Approved in Aug’2014

  8. Jardiance Efficacy as Monotherapy3 Results at Week 24 From a Placebo-Controlled Monotherapy Study of JARDIANCE

  9. Efficacy in Combination3 Results at Week 24 From a Placebo-Controlled Study for JARDIANCE used in Combination with Metformin

  10. Efficacy in Combination3 Results at Week 24 From a Placebo-Controlled Study for JARDIANCE in Combination with Metformin and Sulfonylurea

  11. Adverse Effects of Jardiance3 Adverse Reactions Reported in ≥2% of Patients Treated with JARDIANCE and Greater than Placebo in Pooled Placebo-Controlled Clinical Studies of JARDIANCE Monotherapy or Combination Therapy

  12. Hypoglycemia3

  13. JardiancevsFarxiga

  14. Jardiancevs Farxiga4

  15. Which SGLT-2 inhibitor to use ? Efficacy comparison* as monotherapy compared to placebo in 24 weeks trial *Note: comparison in individual trials and not in head to head clinical trials

  16. Which SGLT-2 inhibitor to use ? • Farxiga: • Carries a warning of Bladder cancer risk. • Newly diagnosed Bladder cancer has been reported in 0.17% of subjects • Use not recommended in Hepatic Impairment (not studied ) • Jardiance: • Can be used in Hepatic Impairment • Invokana: • Use not recommended in Hepatic Impairment( not studied) • Dose related Hyperkalemia • >5.4mEq/mL(12%-27%), ≥6.5mEq/mL (2%)

  17. Effects of SGLT-2 inhibitors • Benefits: • HbA1C decrease 0.5-1% • Weight Loss • No edema • Once a day dosing • A little decrease of SBP • Minimal Hypoglycemia • Drawbacks: • UTI, balanitis, mycoticvulvovaginal infection • Mild transient decrease in eGFR • Not studied in Type 1 diabetes

  18. Current Place in Therapy • FDA approved as adjunct to diet and exercise to control blood glucose. • Also studied in combination with metformin, SU, insulin, pioglitazone • Can be used as second line, after metformin ( because metformin is more studied and approved as first line), however, its cost should be considered.

  19. Conclusion • Since the mechanism of action is independent of the insulin and β-cell function, theoretically it can be used as long as renal function is okay. • It is a new drug ,therefore should be used with extra monitoring, renal function especially. • Long term effects unknown • No studies have been done to see that if the decrease in HbA1C correlates with the decrease in macro and micro vascular complications associated with diabetes.

  20. Ideal patient Which of the following is a candidate for therapy with Jardiance ? A 25 year old pregnant woman with Type 2 diabetes. A 38 year old male, obese patient with Type 2 diabetes having normal kidney function A 68 year old male patient with Type 2 diabetes. A 25 year old male patient with Type 1 diabetes

  21. References 1. http://care.diabetesjournals.org/content/early/2013/03/05/dc12-2625.full.pdf+html 2. EleFerrannini & Anna Solini, SGLT2inhibition in diabetes mellitus: rationale and clinical prospects, Nature Reviews Endocrinology 8, 495-502 (August 2012) 3. Jardiance package insert 4. Farxiga package insert 5. Invoka package insert

  22. Questions ?

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