New Diabetes Therapy Lowers Risk of Death from Cardiovascular Causes and
Could Reduce Weight and Blood Pressure
Written by Bryan Heart Cardiologist, John Steuter, MD
Type 2 diabetes mellitus (T2DM) patients often suffer from obesity and hypertension, increasing their cardiovascular risk. To improve outcomes for patients with T2DM, empagliflozin (Jardiance) a sodium-glucose contransporter 2 inhibitor (SGLT2-I), was approved in 2015 as monotherapy or as an add-on therapy.
Testing the Effectiveness of Empagliflozin in Type 2 Diabetic Patients
The EMPA-REG OUTCOME trial was a randomized, double blind, placebo-controlled trial that investigated cardiovascular outcomes in patients with Type 2 diabetes at high risk of cardiovascular disease (CVD). They were treated with empagliflozin in addition to their standard of care. A group of 7,020 patients were randomized to receive empagliflozin vs. placebo.
Empagliflozin Proves Effective, Reasoning Unclear
Each component of the three-point major adverse cardiac event was evaluated. Patients treated with empagliflozin had a significantly lower risk (38%) of death from cardiovascular causes, but the risk of non-fatal MI and non-fatal stroke remained similar between groups. The primary outcome occurred in a significantly lower percentage of patients treated with empagliflozin than those receiving placebo (10.5% vs. 12.1%).
The reason for improved cardiovascular and renal outcomes is unclear. Overall, patients treated with empagliflozin plus standard of care had:
- Lower HbA1c levels, though not necessarily meeting target values
- Reduction in weight
- Lower blood pressure
- Increased levels of both LDL and HLD cholesterol
Increased weight loss could have contributed to the improved cardiovascular and renal outcomes. However, the reduction in CV risk factors, such as blood pressure and body weight, while statistically significant, were minimal and the differences observed within 2-4 months make it unlikely that the improved CV outcomes were due solely to modification of the CV risk.
Questions Remain, Future Studies May Answer
The question remains as to whether this improvement is a class effect or an outcome specific to empagliflozin. Studies with other SGLT2 inhibitors – canagliflozin (CANVAS) and dapagliflozin (DECLARE-TIMI 58 trial – are in progress, which should help further answer some of these questions.
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