Effect Of Jardiance (empagliflozin) On Heart Attacks, Strokes, And Death In People With Type 2 Diabetes: Results Of EMPA-REG OUTCOME Study | Jessica Pourtaverdi, PharmD | RxEconsult
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Effect Of Jardiance (empagliflozin) On Heart Attacks, Strokes, And Death In People With Type 2 Diabetes Category: Diabetes by - May 14, 2016 | Views: 52090 | Likes: 0 | Comment: 0  

What is Jardiance and its mechanism of action?

Jardiance (empagliflozin) is an oral medication that decreases blood glucose (sugar) in people with diabetes by blocking the kidney from reabsorbing glucose and removing excess glucose through the urine. It does this by blocking the sodium-glucose co-transporter-2 (SGLT2), which is a protein in the kidney that is responsible for reabsorbing glucose back into the body. Jardiance has been shown to reduce body weight, blood pressure, and hemoglobin A1c (HbA1c) by 0.7-1.0%. Lowering high blood glucose can help prevent nerve problems, blindness, and kidney damage in people with diabetes. Proper control of blood glucose can also decrease the risk of getting a heart attack or stroke.

EMPA-REG OUTCOME Trial

The purpose of the "Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients" trial was to determine the long-term cardiac safety and the potential cardioprotective effects of Jardiance in patients with type 2 diabetes who have a high cardiovascular risk.

Study Design

The study was a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Jardiance compared to placebo on cardiovascular events. The study included subjects (n=7,020) that met the following criteria:

  • Ages 18 years and older diagnosed with type 2 diabetes mellitus
  • Body mass index (BMI) of 45 or less
  • Kidney function of at least 30 mL/min
  • Treatment-naive with HbA1c 7.0 to 9.0%
  • Treatment-experienced with HbA1c 7.0 to 10%
  • Had established cardiovascular disease

Subjects were randomized to either receive Jardiance 10 mg, Jardiance 25 mg, or placebo once daily in addition to their home drug regimen. Both doses of Jardiance are the recommended doses in treating type 2 diabetes. Home regimen medications included insulin, statins, blood pressure medications, angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-blockers, or diuretics. The trial duration was from September 2010 to April 2013.

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