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Congress Report: European Society for the Study of Diabetes (EASD) Conference

Congress Report: European Society for the Study of Diabetes (EASD) Conference
  • Cardiometabolic
    Endocrinology and metabolism
  • Diabetes


Resource type



Type 2 diabetes
cardiovascular disease
Glucose lowering agents
DPP-4 inhibitors



Cardiovascular disease with diabetes and possible treatment options to benefit both conditions were one of the highlights of the European Association for the Study of Diabetes (EASD) 2015 conference (Stockholm, Sweden, 14–18 September 2015).

The EMPA-REG OUTCOME study is the latest cardiovascular safety trial of new diabetes drugs designed to comply with the 2008 Food and Drug Administration guidance on new glucose-lowering agents.

This trial of a sodium-glucose co-transporter-2 (SGLT2)-inhibitor enrolled 7020 patients with type 2 diabetes and established cardiovascular disease (prior myocardial infarction [MI], coronary artery disease, unstable angina, stroke or occlusive peripheral arterial disease), a body mass index (BMI) of 45 or less, and an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m2. Patients at 590 sites in 42 countries were randomized on a 1:1:1 basis to empagliflozin 10 mg daily or 25 mg daily or to placebo in addition to standard care (including glucose-lowering therapy).

The primary outcome was a composite cardiovascular endpoint: death from cardiovascular causes, or a nonfatal MI, or a nonfatal stroke. The trial continued until an adjudicated primary outcome had occurred in at least 691 patients. Median observation time was 3.1 years.

The outcomes for the two empagliflozin groups were pooled; results show that the primary outcome occurred less frequently in this pooled empagliflozin group compared with placebo (10.5% vs 12.1%; hazard ratio, 0.86; P<0.001 for noninferiority, P=0.04 for superiority). Empagliflozin did not reduce the rate of nonfatal MI or nonfatal stroke, however, so the difference in the primary endpoint was mainly driven by the 38% relative risk reduction in cardiovascular death, as well as a significant 32% relative reduction in all-cause mortality. This benefit in survival was seen regardless of the cause of death.

This is the first diabetes drug trial that has shown improved outcomes for high-risk cardiovascular patients. In clinical practice, 39 patients would need to be treated with empagliflozin for a 3-year period to prevent one death.

New data analyses were reported at this meeting from four other cardiovascular outcomes trials:

  • The Trial to Evaluate Cardiovascular Outcomes after treatment with Sitagliptin (TECOS) session commenced with an abridged delivery of the results originally reported at the American Diabetes Association (ADA) annual meeting in June 2015. Subsequent subanalyses have confirmed that sitagliptin can be used in type 2 diabetes without worsening heart failure or causing pancreatic cancer.
  • The Evaluation of LIXisenatide in Acute coronary syndrome (ELIXA) session affirmed the good safety profile of lixisenatide in type 2 diabetes, as reported at ADA 2015.
  • Post-hoc analysis of data from the Examination of cardiovascular outcomes: Alogliptin versus standard care (EXAMINE) trial revealed no influence of ACE inhibition on the cardiovascular safety of alogliptin relative to placebo.
  • In Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR)-TIMI, health-related quality of life (HRQoL) was decreased by cardiovascular events but saxagliptin (which increased hospitalisation for heart failure) did not alter HRQoL compared with other treatments.

There are many new data showing that sulphonylureas have less benefit than other oral antidiabetic drugs.

A Bayesian meta-analysis of survival data suggested a higher risk of cardiovascular events with sulphonylureas than with other glucose-lowering agents, and a Swedish database study has shown that second-line treatment with a sulphonylurea compared to a dipeptidyl-peptidase 4 (DPP-4) inhibitor increased cardiovascular risk.

A database study from the USA in type 2 diabetes patients with cardiovascular disease starting a DPP-4 inhibitor or a sulphonylurea showed no increase in hospitalisation for heart failure for either class of agent, and specifically between saxagliptin and sitagliptin.

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