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New Studies Seek to Pin Down Jardiance Heart Benefits

Three sub-analyses parse results of EMPA-REG OUTCOME trial

New analyses of the landmark EMPA-REG OUTCOME trial show that empagliflozin (Jardiance, Boehringer Ingelheim/Eli Lilly) reduced the risk of cardiovascular death in patients with type-2 diabetes and established cardiovascular (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-line and second-line diabetes medications, such as metformin or sulphonylurea.

The companies presented these results from post-hoc analyses at the 53rd Annual Meeting of the European Association for the Study of Diabetes (EASD) in Lisbon, Portugal.

“Now that we have a new option for reducing the risk of cardiovascular death among people with type-2 diabetes, we are striving to better understand if there are differences in how patients can benefit,” said Professor Silvio Inzucchi of the Yale School of Medicine, who presented the data. “These new analyses of the EMPA-REG OUTCOME trial showed empagliflozin was effective in reducing the risk of cardiovascular death in patients with type-2 diabetes and established cardiovascular disease, no matter what the blood sugar levels at the start of the study were or if empagliflozin was added to commonly used oral blood sugar lowering treatments.”

In all four blood sugar level groups at study start (HbA1c levels of less than 7.0%, 7.0% to less than 8.0%, 8.0% to less than 9.0%, and 9.0% or more), 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 decrease in HbA1c level of at least 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 the proportion of patients with hypoglycaemic adverse events were similar between the placebo and empagliflozin  groups in the EMPA-REG OUTCOME trial.

The 7,020-patient EMPA-REG OUTCOME trial results, first published in the New England Journal of Medicine in 2015, had shown that empagliflozin  reduced the relative risk of CV death by 38% compared to placebo in patients with type-2 diabetes and established CV disease on top of standard of care (including glucose-lowering agents and CV drugs). The overall safety profile of empagliflozin was consistent with that of previous clinical trials and current label information.

Source: Boehringer Ingelheim/Eli Lilly; September 12, 2017.

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