Clinical benefit of SGTL2 inhibitor in T2DM with CVD independent from background glucose control

EASD 2017 - Lisbon, Portugal

News - Sep. 12, 2017

Presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal (11-15 September).

New analyses of the EMPA-REG OUTCOME trial show that empagliflozin reduced the risk of CV death in patients with type 2 diabetes (T2DM) and established CV disease, independent of blood sugar control at the start of the study. A reduction in CV death was also seen when empagliflozin was added to common first and second-line diabetes medications, such as metformin or sulphonylurea.

Empagliflozin is an oral, highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor, approved for treatment of adults with type 2 diabetes. SGLT2 inhibition with empagliflozin leads to excretion of excess glucose in the urine in people with T2DM and high blood glucose. In addition, initiation of empagliflozin increases excretion of sodium from the body and reduces the intravascular volume. The glucosuria, natriuresis and osmotic diuresis observed with empagliflozin may contribute to the improvement in CV outcomes.

The EMPA-REG OUTCOME trial was a long-term, multicenter, randomized, double-blind, placebocontrolled tiral of more than 7000 people from 42 countries with T2DM at high CV risk. The effect of 10 mg or 25 mg empagliflozin added to standard of care was assesses as compared with placebo added to standard of care. The primary endpoint was time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke. In the EMPA-REG Outcome trial, treatment with empagliflozin reduced the relative risk of CV death with 38% as compared with placebo.

The current analysis showed that in all four blood sugar level groups at baseline (HbA1c levels of <7.0%, 7.0-8.0%, 8.0-9.0% and ≥9.0%), patients receiving empagliflozin demonstrated a reduction in the risk of CV death compared with placebo. This was consistent with the risk reduction seen in the overall trial population, and seen irrespective of whether blood sugar control was improved following introduction of the study treatment (as measured by a decreased in HbA1c level of ≥0.5% at week 12).

Additional post-hoc analyses showed that when empagliflozin was added to metformin or sulphonylurea, the reduction of CV death compared to placebo was consistent with the overall trial population. These analyses also showed that the proportion of patients with hypoglycemic adverse events were similar between the placebo and empagliflozin groups in the EMPA-REG OUTCOME trial.

Source: press release Boehringer Ingelheim, 12 September 2017

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